Electrosurgical device and methods

ABSTRACT

A controller for an electrosurgical device and related methods and devices are disclosed. The controller has a processing component to: (a) derive a power factor of power applied to the electrosurgical device; and (b) responsive to the deriving a power factor, assign a circuit status to a circuit comprising the electrosurgical device. IF (PF≈0) and ((Vrms/Irms)≧T), THEN the circuit status is “open”. IF (PF≈0) and ((Vrms/Irms)&lt;T), THEN the circuit status is “short”. PF is the power factor. Vrms is the root mean square of a voltage associated with the power applied to the at electrosurgical device. Irms is the root mean square of a current associated with the power applied to the electrosurgical device. T is a threshold value.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/266,903 filed on Sep. 15, 2016 and entitled “ELECTROSURGICAL DEVICEAND METHODS,” which claims priority to U.S. Provisional Application No.62/220,179 filed Sep. 17, 2015 and entitled “Electrosurgical Device andMethods,” U.S. Provisional Application No. 62/279,565 filed Jan. 15,2016 and entitled “Electrosurgical Device and Methods,” and U.S.Provisional Application No. 62/327,852 filed Apr. 26, 2016 and entitled“Electrosurgical Device and Methods,” the entire disclosures of whichare hereby incorporated by reference for all proper purposes, as iffully set forth herein.

BACKGROUND

Field

The present invention relates generally to surgical devices and methods,and more specifically to electrosurgical devices and methods.

Background

In U.S. patent application Ser. No. 14/805,358, now U.S. Pat. No.9,522,034, entitled “Large Volume Tissue Reduction and Removal Systemand Method,” to Johnson et al., a method and device for removing largetissue masses from a patient are described. However, there remains aneed for other new and innovative features.

SUMMARY

An exemplary tissue segmentation device is disclosed. The exemplarydevice has at least one active electrode, a return electrode, amechanical force application mechanism, a voltage sensor, a currentsensor, and a controller. The exemplary controller is configured tocontrol a power output of the segmentation device. The exemplarycontroller has a processing component, responsive to the voltage sensorand the current sensor, configured to execute the following: (a) derivea power factor of power applied to the at least one electrode; and (b)responsive to the deriving a power factor, assign a circuit status to acircuit comprising the at least one electrode, according to thefollowing: IF (PF≈0) and ((Vrms/Irms)≧T), THEN the circuit status is“open”. IF (PF≈0) and ((Vrms/Irms)<T), THEN the circuit status is“short”. PF is the power factor. Vrms is the root mean square of avoltage associated with the power applied to the at least one electrode.Irms is the root mean square of a current associated with the powerapplied to the at least one electrode. T is a threshold value.

An exemplary controller for a tissue segmentation device having at leastone active electrode, a return electrode, a voltage sensor, a currentsensor, and a mechanical force application mechanism is disclosed. Theexemplary controller has a processing component, responsive to thevoltage sensor and the current sensor, configured to execute thefollowing: (a) derive a power factor of power applied to the at leastone electrode; and (b) responsive to the deriving a power factor, assigna circuit status to a circuit comprising the at least one electrodeaccording to the following: IF (PF≈0) and ((Vrms/Irms)≧T), THEN thecircuit status is “open”. IF (PF≈0) and ((Vrms/Irms)<T), THEN thecircuit status is “short”. PF is the power factor. Vrms is the root meansquare of a voltage associated with the power applied to the at leastone electrode. Irms is the root mean square of a current associated withthe power applied to the at least one electrode. T is a threshold value.

An exemplary method of tissue segmentation is disclosed. The exemplarymethod includes providing a tissue segmentation device having at leastone active electrode, a return electrode, a mechanical force applicationmechanism, a voltage sensor, and a current sensor. The exemplary methodincludes deriving a power factor of power applied to the at least oneelectrode, and responsive to deriving a power factor, assigning acircuit status to a circuit comprising the at least one electrodeaccording to the following: IF (PF≈0) and ((Vrms/Irms)≧T), THEN thecircuit status is “open”; IF (PF≈0) and ((Vrms/Irms)<T), THEN thecircuit status is “short”. PF is the power factor. Vrms is the root meansquare of a voltage associated with the power applied to the at leastone electrode. Irms is the root mean square of a current associated withthe power applied to the at least one electrode. T is a threshold value.

Another exemplary tissue segmentation device is disclosed. The exemplarydevice has at least one active electrode, a return electrode, amechanical force application mechanism, a voltage sensor, a currentsensor, and a controller. The exemplary controller is configured tocontrol a power output of the segmentation device. The exemplarycontroller has a processing component, responsive to the voltage sensorand the current sensor, configured to execute the following: (a) derivean impedance to power applied to the at least one electrode; and (b)responsive to the deriving the impedance, assign a circuit status to acircuit comprising the at least one electrode, according to thefollowing: IF (Z>T1), THEN the circuit status is “open”; and IF (Z<T2),THEN the circuit status is “short”; where Z is the impedance; T1 is afirst threshold value; and T2 is a second threshold different from thefirst threshold value.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a tissue segmentation device according to someembodiments;

FIG. 2 is a diagram of some electrical and mechanical components of anexemplary electrosurgical device;

FIG. 3 illustrates a perspective view of an introducer;

FIG. 4 illustrates an introducer;

FIG. 5 illustrates an introducer;

FIG. 6 illustrates a sensing device;

FIG. 7 is a flowchart depiction of a controller and method;

FIG. 8 is a flowchart of a method of controlling a tissue segmentationprocedure;

FIG. 9A is a first portion of a flowchart of a tissue segmentationcontrol method, and FIG. 9B is a continuation of the flowchart in FIG.9A;

FIG. 10A is a first portion of a flowchart of a multiplexed tissuesegmentation control method, FIG. 10B is a continuation of the flowchartin FIG. 10A, and FIG. 10C is a continuation of the flowchart in FIG.10B;

FIG. 11 illustrates an electrosurgical device and system for detecting adistance of electrode travel;

FIG. 12 is a side section view of a tissue segmentation device;

FIG. 13 is a perspective view of a disposable lumen assembly;

FIG. 14 illustrates a device having disposable and reusable portions;

FIG. 15 is a perspective view of a removal device;

FIG. 16 is a perspective view of the device in FIG. 15 with somecomponents removed;

FIG. 17 is a top view of some components of the device in FIG. 15;

FIG. 18 is a perspective view of some components of the device in FIG.15;

FIG. 19 is a perspective view of some components of the device in FIG.15;

FIG. 20 is a perspective view of a removal device with an introducer;

FIG. 21 is another view of the device in FIG. 20;

FIG. 22 is another view of the device in FIG. 20;

FIG. 23 illustrates a tensioning instrument;

FIG. 24 is a perspective of an introducer prior to insertionpreparation;

FIG. 25 is a perspective view of the introducer in FIG. 24 prepared forinsertion;

FIG. 26 is a side section view of an inflator;

FIG. 27 illustrates several views of tissue removal bag components;

FIG. 28 illustrates a bag having an apron;

FIG. 29 illustrates a bag having a drawstring;

FIG. 30 illustrates a bag;

FIG. 31 illustrates several views of inflation mechanisms for a tissueremoval bag;

FIG. 32 illustrates two side views of components for an ultrasonic orvibratory segmentation device;

FIG. 33 illustrates a side section view of some components of anelectrosurgical device;

FIG. 34 illustrates a partial transparent perspective view and a partialtransparent side view of a removal bag;

FIG. 35 illustrates a top view of a return electrode;

FIG. 36 depicts an electrode color coding means;

FIG. 37 depicts an electrode coding means;

FIG. 38 illustrates a resistor element;

FIG. 39 illustrates a crimp connector with resistor;

FIG. 40 illustrates a crimp connector with a resistor ring;

FIG. 41 illustrates a flowchart of an active electrode connectorrecognition method;

FIG. 42 illustrates top and side views of a tissue removal bag;

FIG. 43 illustrates a method of using an inflatable tissue removal bag;

FIG. 44 illustrates several views of a marking instrument;

FIG. 45 illustrates several views of a tissue removal bag having markingfeatures;

FIG. 46 illustrates two perspective views of ink marking components;

FIG. 47 illustrates several views of a tissue removal bag;

FIG. 48 illustrates a flowchart of a surgical method;

FIG. 49 illustrates several views of an electrosurgical device having anemergency release mechanism;

FIG. 50 illustrates a release mechanism;

FIG. 51 illustrates a release mechanism;

FIG. 52 illustrates a perspective view of some components of anelectrosurgical device;

FIG. 53 illustrates a side view of a cutting wire embodiment;

FIG. 54 illustrates a side partial section view of a double retrievalbag with wire mesh and inflation mechanism;

FIG. 55 illustrates various views of a collapsing retrieval basket;

FIG. 56 illustrates a rotating power electrode cutting device;

FIG. 57 illustrates rotating wire electrodes having sharp leading edges;

FIG. 58 illustrates a single electrode wire embodiment;

FIG. 59 illustrates a bipolar device with active and return wiresconstricting a tissue specimen;

FIG. 60 illustrates a cutting and grasping loop in a retrieval bag;

FIG. 61 illustrates a stationary cutting mechanism and moving tissuearrangement;

FIG. 62 illustrates a push/pull grid cutting mechanism;

FIG. 63 illustrates a multistage rigid cutting mechanism;

FIG. 64 illustrates a stationary cutting electrode system;

FIG. 65 illustrates a skewer mechanism for tissue segmentation;

FIG. 66 illustrates a spiral electrode cutting mechanism;

FIG. 67 illustrates an electrode construction having thread woven withmetal filars;

FIG. 68 illustrates an electrode construction with bipolar/bifilar wirepairs;

FIG. 69 illustrates a square wire electrode;

FIG. 70 illustrates a removal bag;

FIG. 71 illustrates a wire and bag construction;

FIG. 72 illustrates a bag and return electrode construction;

FIG. 73 illustrates a dual bag construction with an inner bag configuredto constrict tissue;

FIG. 74 illustrates a dual bag construction with an outer bag configuredto constrict tissue;

FIG. 75 illustrates energy delivery using an in-cord signal controller(multiplexing);

FIG. 76 illustrates a retrieval bag specimen capture and cut device;

FIG. 77 illustrates another view of the device in FIG. 72;

FIG. 78 illustrates guides for wire loops;

FIG. 79 illustrates a cam tube for organizing or sequencing electrodes;

FIG. 80 illustrates an electrode loop with opposing springs for tensioncontrol;

FIG. 81 illustrates a shaft construction;

FIG. 82 illustrates another shaft construction

FIG. 83 illustrates torsion springs for tensioning wires/electrodes;

FIG. 84 illustrates wire activation using a cam and lobe;

FIG. 85 illustrates a wire length lock mechanism;

FIG. 86 illustrates an introducer instrument and removal bag;

FIG. 87a illustrates various features of a wrap-around removal bag, FIG.87b illustrates various features of the wrap-around removal bag in FIG.87a , and FIG. 87c illustrates various features of the wrap-aroundremoval bag in FIG. 87 a;

FIG. 88 illustrates another removal device;

FIG. 89 illustrates details of a wire; and

FIG. 90 illustrates details of another wire.

FIG. 91 is a cross-section view of some components of a bag assemblywith leak detection;

FIG. 92 is a side partial section view of some components of a bagassembly with leak detection;

FIG. 93 is a side section view of some components of a bag assembly withleak detection;

FIG. 94 is a side section view of some components of a bag assembly withleak detection;

FIG. 95 is a side section view of some components of a bag assembly withleak detection;

FIG. 96 illustrates partial top and side section views of somecomponents of a bag assembly with leak detection;

FIG. 97a illustrates side section views of some components of a bagassembly with leak detection, FIG. 97b illustrates a side section viewof the components in FIG. 97a , and FIG. 97c illustrates a side-sectionview of the components in FIG. 97 a;

FIG. 98 illustrates a perspective view of some components for wiremanagement;

FIG. 99 illustrates some components for wire management; and

FIG. 100 illustrates a side section view of some components of a wiremanagement system.

DETAILED DESCRIPTION

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

In one exemplary application, and as illustrated in FIG. 1, an advancedelectrosurgical system 100 may be provided. The system 100 may beconfigured to perform some or all of the functions, such as tissuesegmentation and/or removal, described in Applicant's InternationalApplication PCT/US15/41407, entitled Large Volume Tissue Reduction andRemoval System and Method, filed on Jul. 21, 2015, and having a prioritydate of Jul. 22, 2014, the entire contents of which are incorporatedherein by reference for all purposes, as if fully set forth herein. Thesystem 100 may include an electrosurgical device 102 and a generator 104coupled together by a number of leads 106. The generator 104 may includea controller 108.

Except as where otherwise stated herein, the term “segmentation device”shall be understood to include a device for dividing tissue, and mayinclude a mechanical segmentation action, and/or an electrosurgicaldissection action, for example a bipolar segmentation action, or amonopolar action.

In some embodiments, and as illustrated in FIG. 2, the generator 104 mayinclude a datastore 110 for storing one or more sets of tissuesegmentation parameters. The tissue segmentation parameters may includeparameters associated with a normal or expected response during anelectrosurgical procedure, and may be related to tissue segmentationvoltage, current, power factor angle, impedance, power, energy,electrode or wire rate of travel, electrode or wire distance of travel,and/or mechanical segmentation force applied to tissue by theelectrode(s) or wire(s). The datastore 110 may be a component of orseparate from the controller 108.

The tissue segmentation parameters are obtained by analytical and/orexperimental methods and are targeted boundary values that ensureoptimal operation of the system 100 or components thereof, preferablywhile maintaining a safe tissue temperature.

In some embodiments, a tissue segmentation voltage parameter Vmin isdefined as the minimum voltage required to begin the initiation of asegmentation cut by providing an arc through an active electrodeexposure area between the electrode/wire and the tissue. In someembodiments, the tissue segmentation voltage parameter Vmin is definedas the minimum voltage required to sustain the segmentation cut. Thetissue segmentation voltage parameter Vmin can be calculated byconsidering the dielectric value of the electrode or wire coating, thecoating thickness, and the uniformity of the coating. The tissuesegmentation voltage parameter Vmin may also or alternatively bedetermined experimentally by measuring the voltage between theelectrode/wire and return at initiation and/or during a segmentation cutof a control tissue.

In some embodiments, the tissue segmentation current parameter Imin isdefined as the minimum current required to meet the current densityneeded to create a tissue segmentation cut. In some embodiments, thetissue segmentation current parameter Imin is defined as the minimumcurrent required to sustain a cutting effect. The tissue segmentationcurrent parameter Imin value may be calculated by multiplying a knowncurrent density that achieves a desired cutting effect in a controltissue by an active electrode surface area. The tissue segmentationcurrent parameter Imin may also or alternatively be determinedexperimentally by increasing the RF current applied to a control tissueuntil cutting occurs and measuring the current delivered to the controltissue. In some embodiments, the control tissue may be tissue of thepatient during an electrosurgical procedure.

In some embodiments, a power factor angle PFAcut variable is measuredduring an electrosurgical procedure on a patient. The power factor anglePFAcut variable may be determined by measuring the phase angle betweenthe voltage and current waveforms delivered to the electrosurgicaldevice, and is a representation of the complex load impedance providedby the system, including the tissue, to the generator during theelectrosurgical procedure. The power factor angle PFAcut variable may bemeasured and tracked, to determine if a short circuit condition or opencircuit condition between an active electrode or active segmentationwires and a return electrode exists.

A direct impedance measurement from the controller 108 to determine ashort circuit is difficult as the series cable inductance becomesdominant. Applicant has determined that the power factor angle PFAcutduring a short circuit will appear mostly inductive and have a phaseangle near 90 degrees. Therefore, a short circuit power factor angleparameter PFAshort may be experimentally determined by measuring thelowest, or least inductive, power factor angle PFAcut variable while ashort circuit is intentionally applied between the active and returnelectrodes during RF activation. The lowest power factor angle PFAcutvariable may then be defined as the short circuit power factor angleparameter PFAshort.

Similarly, a direct impedance measurement for an open circuit isdifficult, due to the parallel system capacitance. The power factorangle PFAcut variable during an open circuit will appear mostlycapacitive and have a phase angle near −90 degrees. The open circuitpower factor angle parameter PFAopen, may therefore be experimentallydetermined by measuring the highest, or least capacitive, power factorangle PFAcut variable while an open circuit condition is known to existbetween the active and return electrodes during RF activation. Thehighest power factor angle PFAcut variable may then be defined orassumed as the open circuit power factor angle parameter PFAopen.

In some embodiments, an open circuit and/or short circuit may bedetermined using the power factor PF instead of the power factor anglePFA previously described. The power factor is the ratio of the actualpower being delivered, or real power Preal, to the product of the RMSvoltage Vrms and the RMS current Irms. The product of the RMS voltageVrms and the RMS current Irms may be referenced herein as the apparentpower. This ratio is 1.0 when the real power and apparent power are thesame, as would be the case when a purely resistive load is applied. As amore inductive or a more capacitive load is applied, the phase shift ofthese loads reduces the value of the ratio to approach zero as the realpower reduces but the apparent power remains the same. In this manner,the power factor PF may be used instead of the power factor angle PFA,thereby providing or enabling the detection of a minimum power factorthreshold for cutting, PFcut, a short circuit power factor threshold,PFshort and an open circuit power factor threshold, PFopen.

As illustrated in FIG. 7A, to measure, detect, and/or derive the PowerFactor PF, the controller 108, 708 may be coupled to or responsive tovoltage and current sensors (not illustrated) that are designed with abandwidth that will accommodate a fundamental RF frequency of thewire(s) (e.g. wire(s) 151 in FIG. 1).

In some embodiments, an analog/digital converter (A/D converter) may beprovided and coupled to a field programmable gate array (FPGA),microcontroller, or other processing component 712 to sample the voltageand current sensors. A sampling rate of at least greater than 2 timesthe fundamental RF frequency may be provided in some embodiments. Insome embodiments, the sampling rate may be greater than 5 times thefundamental RF frequency, thereby reducing sampling error.

The controller 108, 708 may calculate the average real power of theelectrical load by using the instantaneous sampled voltage multiplied bythe instantaneous sampled current values, averaged over a samplingwindow having N cycles of the fundamental RF Frequency. Those skilled inthe art understand that the value of N may be selected based on theaccuracy of the measurement; as N increases, the accuracy of themeasurement increases. The value of N may be selected based on thesystem response time. As N decreases, the system response time willdecrease. The value of N may be selected based on simplification of thecalculations, for example selecting N as a power of 2. N may be selectedbased on other means, including, but not limited to, balancing systemresponse time, simplification of calculations, and/or accuracy of themeasurements.

Continuing with FIG. 7A, the controller 108, 708 may calculate or derivethe RMS voltage Vrms by squaring the instantaneous sampled voltageaveraged over a window of N cycles of the fundamental RF frequency. Thecontroller 108, 708 may calculate or derive the RMS current Irms bysquaring the instantaneous sampled current averaged over a window of Ncycles of the fundamental RF frequency.

Using the calculated values of voltage Vrms, current Irms, and powerPreal previously described, the power factor, PF, is the real power,Preal, divided by the product of the RMS voltage Vrms and RMS currentIrms. As previously described, if the load impedance is an open or shortcircuit, the power factor PF, approaches zero.

If the apparent impedance Z (Z=Vrms/Irms), is above a predeterminedthreshold and the power factor PF is near zero this identifies an opencircuit. In some embodiments, an open circuit may indicate a cut iscomplete. In some embodiments, an open circuit in combination with adetected distance of proximal travel of one or more wires/electrodes 151may indicate a cut(s) is complete.

Continuing with FIG. 7A, if the apparent impedance Z is below thisthreshold, and the power factor PF is near zero, this indicates a shortcircuit between an active electrode or wire (e.g. wire 122, 124) and areturn electrode 126.

In some embodiments, the average real power Preal may be detected orderived using the voltage and current sensors as previously described;however the output of the sensors may be connected to an analogmultiplier to obtain the instantaneous real power Preal. The output ofthe multiplier may then be coupled to an analog circuit with an inherentcapacitance to provide the window for averaging the real power Preal.The average RMS voltage Vrms and RMS current Irms may also be measuredusing an analog RMS voltage and RMS current sensing circuit thatprovides an RMS analog output. The RMS output of these sensors may alsobe connected to a multiplier to obtain the instantaneous apparent powerand, as previously described for the real power measurement, the outputof the multiplier may be connected to an analog circuit with an inherentcapacitance to provide the window for averaging the apparent power. Thiscircuit may be read with an A/D converter so that the power factor PFcan be easily calculated by dividing the average real power analogoutput by the average apparent power output.

In some embodiments, the output of the real power multiplier and theoutput of the apparent power multiplier may be coupled directly to ananalog divider to obtain the instantaneous power factor PF. This outputmay be read with an A/D converter to directly measure the power factor,or may be connected to an analog circuit with an inherent capacitance toprovide a window for averaging the power factor.

In some embodiments, a purely analog method of power factor calculationmay include the use of comparators as threshold detectors to provide ananalog short circuit and/or open circuit detection that does not requirea microprocessor, FPGA or other software, or RTL programmableinstruction set to perform.

The impedance Zcut variable may be deduced from the voltage V andcurrent I variables (see, e.g. FIG. 2) at leads 114, 116, and may beused to compare against a minimum tissue impedance parameter Zmin and amaximum tissue impedance parameter Zmax. The tissue impedance parametersZmin, Zmax are affected by the active electrode surface area, thecoating properties of the active electrode wire, the tissue type, andthe tissue hydration, and may be experimentally determined by measuringthe range of impedance values during a cutting process in a controltissue or the patient tissue under controlled conditions.

Relatedly, the power variable Pcut may be deduced from the voltage V andcurrent I values (see FIG. 2) at leads 114, 116, and may be comparedagainst the minimum power parameter Pmin and the maximum power parameterPmax. The minimum power parameter Pmin may be determined or defined bythe minimum power Pmin required to meet the power density needed toinitiate or sustain a cutting effect, as previously described herein.The maximum power parameter Pmax may be determined or defined as a valuethat will deliver a segmentation or cutting effect without excessivecharring, desiccation of tissue, and/or steam or smoke generation. Insome embodiments, the minimum and maximum power parameters Pmin, Pmaxmay be calculated by multiplying the desired power densities by theactive electrode surface area. The active electrode surface area may bedefined or determined as illustrated and described in Applicant'sco-pending application PCT/US15/41407. The minimum power parametervalues Pmin, may also be determined experimentally by adjusting RF poweruntil the desired cutting effect is observed and measuring the powerdelivered to the tissue.

In some embodiments, a method of improving the power efficiencydelivered from the generator to the tissue may be provided. In someembodiments, the controller may use power factor correction. Powerfactor correction may be achieved by the use of a variable capacitancethat may be adjusted by the controller (see e.g. FIG. 2) to cancel outthe cable inductance of the system. The controller 108 may continuouslymonitor the power factor phase angle PFAcut and may use this value toadjust a variable capacitance applied in parallel between an activeelectrode or wire 122, 124 and a return electrode 126 coupled to thecontroller 108. This changes the PFAcut angle allowing the controller tocontrol the phase to achieve a near 0 degree phase angle resulting inthe maximum power efficiency to perform the cut. This technique can beused to maximize the power delivered to the tissue which can providefaster cutting or allow larger tissue specimens to be cut effectively.

The energy variable Etissue delivered to the tissue, is defined by theaccumulated energy applied to the tissue during the RF activation. Theenergy variable Etissue may be deduced by accumulating the real powercomponent from the voltage V and current I values (see FIG. 2) such asat leads 114, 116 on a cycle by cycle basis. Using the energy variableEtissue delivered to the tissue, a relationship between the energydelivered to the tissue and a resulting temperature rise of the tissuespecimen may be determined using a control tissue sample of known volumeand/or size. Using this relationship, the energy variable Etissue may becompared to a maximum energy parameter Emax, to ensure that the tissuetemperature does not exceed an intended value or beyond a temperaturedeemed safe.

The rate of travel variable Rtravel is defined as the distance of travelof a tensioning mechanism or cutting electrode or wire over a fixedperiod of time, and may be compared to a minimum rate of travelparameter Rmin and a maximum rate of travel parameter Rmax, to confirmif the cutting electrode or wire (see e.g. FIG. 1) is travelling at arate that is consistent with a safe cutting rate and properlyfunctioning system 100. The rate of travel variable Rtravel of theelectrode is an important variable to ensure the low temperature cuttingdesired. With a fixed power delivery, as the rate of travel Rtravel ofthe electrode through the tissue is reduced, the total energy deliveredto the tissue increases and the resulting temperature of the localizedtissue near the electrode will increase at a faster rate. If theresulting temperature rise is too much or too fast, patient injury mayoccur.

The minimum rate of travel parameter Rmin may be determinedexperimentally by adjusting the power P, derived from the voltage V andcurrent I applied to the active electrodes or wires, and measuring therate of travel that achieves the maximum allowable temperature rise onthe surface of a control tissue specimen. In some embodiments, themechanical force F may be adjusted to a known mechanical force F of zeropounds-force or more. In addition to varying power and force, avibration or other dynamic load may be applied to the wires to speed itsprogress upon sensing a low rate of travel.

The maximum rate of travel parameter Rmax may be determinedexperimentally by measuring the rate of rise with no mechanical F on thetensioning mechanism or electrode(s) or wire(s). This value indicates acondition where the wires are not applying a force to the tissuespecimen, such as a broken wire.

Many methods may be used to measure or determine the rate of travel. Insome embodiments, and as is illustrated in FIG. 6, an optical motionsensor 676 is provided in near proximity to a spring or forceapplication mechanism 674. The optical motion sensor may be focused on alocation of the spring such that as the spring moves, the optical sensorarea of focus could detect this motion as linear translation. In someembodiments, the motion may be detected as a motion within a plane.

In some embodiments, a plurality of motion sensors may be provided. Theplurality of motion sensors may be configured to compare images at timeT0 against images at time T0+1 to determine a direction and/or adistance of movement of the tensioning mechanism, cutting electrode,and/or wire.

In some embodiments, the sensor(s) have one or more integrated circuits,a sensor optical lens, and a light source. In some embodiments, thesensor(s) have separate components specifically for the application. Thearea of focus on the spring may be near the spool of the spring cylinderon the flat side of the spring coil so that the movement of the springappears as a horizontal, transverse, or X direction motion. In someembodiments, the area of focus of the optical sensor is along theextended portion of the spring away from the spring spool or cylinder.In some embodiments, the area of focus is on the top of the spoolcylinder such that as the spring moves, the sensor is configured todetect rotational movement that is detected as both X and Y movement ortransverse and longitudinal movement.

In some embodiments, one or more optical sensors are provided andconfigured to detect contrast changes rather than creates images. Thecontrast changes can be surface irregularities in the spring or forceapplication mechanism or can be patterns that are created on the springsurface. In some embodiments, preselected or known and regular intervalsof contrasting patterns may be provided on the moving component, such asthe tensioning mechanism, cutting electrode, or wire, and one or moreoptical sensors are configured to count the number of patterns movingpast the area of focus to determine rate of travel and distance oftravel. In some embodiments, the patterns are configured to provide areference interval to measure the rate. The patterns may be separatepatterns integrated or modulated into a primary pattern or near aprimary pattern as a secondary pattern, so as to provide additionalinformation, such as absolute distance traveled, beginning or end oftravel markers, and/or key points of distance traveled.

In some embodiments, the device may be configured to adjust a power inresponse to information detected and/or communicated by the sensor orplurality of sensors. For example, the device may be configured toincrease a segmentation power being applied to a cutting electrode inresponse to a determination that the tensioning mechanism, electrode, orwire is translating or moving at a less than preferred rate. As anotherexample, the device may be configured to decrease a segmentation powerbeing applied to a cutting electrode in response to a determination thatthe tensioning mechanism, electrode, or wire is translating or moving ata greater than preferred rate.

In some embodiments, a wheel having a known diameter may be provided incontact with the spring or force application mechanism, and a measuredrotation of the wheel provides an indication of spring travel. Therotation of the wheel can be measured by including spokes in the wheelof known width or angle and optically counting the number of spokesobserved by a light source and detector located on opposing sides of thewheel.

In some embodiments, the wheel is mechanically coupled to apotentiometer or variable resistor. As the wheel rotates, the resistanceof the potentiometer changes; the change in resistance may be used tocalculate the corresponding change in travel of the spring.

In some embodiments, a resistive film is provided on an exposed topsurface of the wheel. A variable resistance along the surface may beprovided, varying from a low impedance value to a high impedance valueas the wheel rotates. A pair of contacts can be placed in the center andedge of the resistive film surface such that rotation varies theresistance, and the rotation can be calculated by tracking these changesin resistance.

In some embodiments, the device may be configured to detect acapacitance change to determine a rate or distance of travel. In someembodiments, an electrical plate that does not cover the entire wheelsurface is provided, such as a semicircle, having a second conductivesemicircle. Applying a time varying voltage between these two plates,the change in capacitance may be measured as the wheel rotates. In thisapproach the change in travel of the spring can be calculated in asimilar manner as the previous example with a resistive film.

In some embodiments, an encoder is mechanically coupled to the spring orforce application mechanism to indicate a rate or distance of travel.The encoder may provide waveforms that can be used to determine a rateof travel using the phase of the two waveforms.

In some embodiments, and output of one or more sensors or a sensingcircuit provides information that is used to calculate or infer a rateof travel. The electrosurgical instrument 102, which may also bereferenced herein as a segmentation instrument, may use this informationdirectly to determine if the rate of travel is acceptable. Thesegmentation instrument may include a processing device, an analogcircuit, and/or a digital circuit to calculate, process, and/or track asensor output. In some embodiments, the device may initiate an actionresponsive to the information from the one or more sensors, such as, forexample only when a distance or rate of travel is outside an acceptableor expected range.

It may be beneficial to scale this information into units that aremeaningful to users such as cm/second. In some embodiments, the devicehas a processor configured to scale a digital, analog, or other signalinto an informative output in a manner known to those skilled in theart. One benefit of using this method is that the motion of the springcan be quantified in a traceable manner that can be compared to externalmeasurement equipment. An additional benefit is that correctionalgorithms can be applied if a non-linearity is observed in the rate oftravel through the entire range of travel of the spring or forceapplication mechanism.

In some embodiments, the segmentation instrument has a processing devicein communication with the sensor(s). In some embodiments, thesegmentation device may have a microprocessor, state machine, and/orfield programmable gate array (FPGA) to perform the processing and/orallow a user to configure the segmentation device.

In some embodiments, the signals are transmitted from the segmentationinstrument to a separate device, such as a controller or anotherprocessing unit on-site or off-site, to perform this processing. Thedistance of travel variable Dtravel may be measured directly from atensioning device in the electrosurgical device 102, and may be used tocompare against a pre-tension distance of travel parameter Dpreten and acut complete distance of travel parameter Dcomplete. The pre-tensiondistance of travel and cut complete distance of travel parametersDpreten, Dcomplete are calculated by the tensioning mechanism and activeelectrode assembly design such that the pre-tension distance of travelparameter Dpreten indicates the minimum distance achieved duringpre-tensioning with the largest intended tissue specimen, and the cutcomplete distance of travel parameter Dcomplete indicates the maximumdistance achieved when the active electrode wires have finished the cut.See Applicant's application PCT/US15/41407 for details of the tensioningdevice. The variable Dtravel may also be used to measure the travel ofeach separate tensioning mechanism after pre-tension is applied. Thesevalues may be used to approximate the volume and/or shape of the tissuespecimen by comparing the Dtravel at the completion of pre-tensionagainst Dpreten. By using this approximation, the maximum energydelivered to the tissue parameter Emax, may be adjusted to accommodatethe tissue specimen being segmented.

Those skilled in the art will recognize that the methods and orcomponents employed to measure the rate of travel previously describedherein may be used to determine, calculate, or infer a distancetraveled. In some embodiments, a distance traveled is calculated ordetermined as a relative distance. In some embodiments, a measureddistance is calculated or determined as an absolute distance, forexample, where an initial position is known or if absolute positionindicators are included, such as previously described.

In some embodiments, the device may be configured to transmit a signalor information related to the segmentation to the user. For example, thesegmentation device may be configured to indicate a percentage ofcompletion of a segmentation procedure, a rate of completion, a rate oftravel, an absolute distance traveled, and/or a relative distancetraveled.

In some embodiments, the segmentation device may be configured totransmit an auditory or visual warning signal to the user where the rateof segmentation, rate of travel, and/or other parameters are not withinan expected range, such as an expected range that would be associatedwith a segmentation power being applied to the electrode(s). That is, anexpected range of a travel rate may be associated with a particularpower level and/or segmentation force. If the actual travel rate isoutside the expected range, this may be an indication of a problem withthe procedure, and the user may need to halt and/or adjust theprocedure.

With brief reference now to FIGS. 20-22, the pre-tensioning of activeelectrode wires is now described. In some embodiments, an introducertube mechanism 1500 may be provided to enable a user to pre-tension thewires against the tissue sample, that is, to bias the wires towards thetissue sample. Upon initiating this mechanism 1500, the introducer tube1501 will extend in length towards the tissue sample (instead of pullingthe tissue sample back towards the introducer tube). This mechanism 1500may include a nested, spring-loaded tube which telescopes out towardsthe specimen upon release of the mechanism. This extending introducertube may include, but is not limited to, a jack-screw mechanism whichunscrews to extend the introducer tube, inflatable bladders which extendthe multi-piece introducer tube, and/or manually extending the nestedintroducer tube with the aid of self-locking teeth to prevent theextended introducer tube from collapsing back on itself

The extendable distal end portion of the segmentation instrument may beinserted into the cavity of the patient and in direct contact with thetissue to be segmented. This distal tip of the instrument tube, termedthe introducer tube 1501, may have the opportunity to be a point of highfrictional drag between the active segmenting wires and thetissue/introducer tube interface. Some embodiments therefore includedentals 1505 (see e.g. FIG. on a distal end of introducer tube—whichallows the introducer tube to be firmly contacted with the tissuespecimen, yet gives space for the segmentation wires to freely retractthrough the tissue and into the segmentation instrument without gettingpinched between the tissue specimen and the distal tip of the introducertube.

Some embodiments include a standoff platform 1506 to reduce friction. Insome embodiments, the standoff 1506 may be a spherical standoff. Thoseskilled in the art will understand, however, that the platform 1506 maybe in the form of any shape, as long as the platform provides intimatecontact with the tissue and provides a clear space through which theactive segmentation wires can travel. In some embodiments, the platformprovides intimate instrument/segmentation tissue contact while stilloffering an open space where the segmentation wires can more freelytravel between the tissue and the distal tip of the introducer tube 1501(on the segmentation instrument).

In some embodiments, a distal tip of the introducer contains alubricious and high temperature insert, such as PTFE, that reduces thefriction of the wires traveling through the tube and into theinstrument, as is illustrated in FIG. 3.

Returning now to FIG. 4, the introducer 400 may have two or morefeatures to maintain pneumoperitoneum. The introducer may have aninflation ring 401 around the distal portion of the device that isplaced near the inside surface of the peritoneum. in some embodiments, asecond mechanical sealer 402 is provided, that may be adjusted downwardtoward the incision in a manner that compresses the tissue between theinflatable ring 401 on the inside of the peritoneum and the mechanicalsealer 402 on the outside of the peritoneum. In some embodiments,inflation may be achieved by using a separate syringe attached to theintroducer when desired. In some embodiments, a syringe-like feature isincorporated into the handle of the introducer 403 such that as theproximal handle is moved it creates a pressure that is channeled to theinflatable ring.

Turning now to FIG. 5, some embodiments include a flexible membrane 501near the distal end of the introducer 500. A proximal section of theintroducer 502 may slide toward the distal end of the introducer 504 byapplying a force on the handle 505, causing an interference between aramp 506 on the distal end and semi-rigid fingers 507 coupled to theproximal section. The interference may cause the semi-rigid fingers toexpand outward causing the flexible membrane 501 to expand outward awayfrom the introducer creating a protrusion that can be used to seal theinside of the peritoneum. A mechanical sealer 508 can be applied aspreviously described to provide compression at the incision site.

In some embodiments, a flexible membrane is located near the distal endof the introducer. Semi-rigid “fingers” may be arranged around thecircumference of the introducer shaft, under the membrane, and coupledto the proximal section of the introducer. Under the “fingers” is a rampcoupled to the distal most portion of the introducer located such thatthe ramp begins at the distal edge of the fingers in the normalposition. When the proximal portion of the shaft is advanced toward thedistal end of the introducer, the fingers are extended away from theintroducer also extending the flexible membrane. This creates aprotrusion that can be used to seal the inside of the peritoneum. Amechanical sealer can be applied as previously described to providecompression at the incision site.

In some embodiments, the introducer has a film attached near the distalend of the device. This film is arranged in a cross sectional axis ofthe introducer so that when the introducer is withdrawn to the properlocation, the film may provide a seal to the incision site. In thisembodiment, the introducer will be hold in place the by the user tomaintain pneumoperitoneum or the use of the seal on the outside surfaceas previously describe can be used to help with holding the introducerin the proper location.

Those skilled in the art can understand that any combination of flexiblemembrane, inflation ring, or mechanical sealer can be used on the insideand/or outside surface of the incision site to provide a seal thatmaintains pneumoperitoneum. In addition, the distal most portion of thehandle can incorporate many user interface features to enact the sealingfeatures, including a slide that applied inflation or motion, a sectionof the tube that can be moved up or down along the shaft of theintroducer, or a protrusion that acts and a lever to create the motionrequired to initiate the sealing.

In some embodiments (see e.g. FIG. 4), the coupling of the drawstring tothe distal portion of the introducer 403 can be included with thesealing feature to provide multi-functionality of the introducer. Thisincreases the efficiency of the procedure by minimizing the effortrequired to perform the bag insertion, sealing of the peritoneum duringtissue loading and allowing easy withdrawing of the introducer while atthe same time pulling the bag opening through the incision site.

In some embodiments, the generator 104 may be coupled to a first set 120of first, second, and third leads 114, 116, 118 for detecting and/orsending analog and/or digital signals associated with tissuesegmentation. For example, the analog and/or digital signals may includesignals for controlling tissue segmentation variables, including, butnot limited to voltage, current, impedance, power, rate of travel,distance of travel, and/or mechanical segmentation forces to be adjustedor applied during a tissue segmentation procedure. The first set 120 ofleads may be associated with a first cutting wire 122 coupled to theelectrosurgical device 102. A second set 130 of leads, which maylikewise include first, second, and third leads, may be associated witha second cutting wire 124. The sets 120, 130 of leads may include moreor fewer leads per set, and more or fewer sets.

In some embodiments, the controller 108 may be configured to cause thecutting wires 122, 124 to apply radio frequency (RF) power to a tissuespecimen (not shown) for segmentation and removal. Although just twowires 122, 124 are illustrated in FIG. 2, the controller 108 may beconfigured to control a number of tissue segmentation variablesassociated with a number of wire sets.

With reference now to FIG. 7, the controller 108, 708 may be configuredto control a number of tissue segmentation wires in a time multiplexedmanner. For example, the controller 108, 708 may include anon-transitory tangible processor-readable medium 710 includinginstructions to effectuate the methodologies described herein. Forexample, the non-transitory instructions may be accessible by aprocessing component 712 to execute one or more methods.

One method may include comparing 714 at least one detected tissuesegmentation variable with a tissue segmentation parameter and/orcomparing 716 at least one detected tissue segmentation variable with asecond tissue segmentation variable, and adjusting 718 a tissuesegmentation control signal in response to either comparing 714, 716.

The controller 108, 708 may be further configured to control the tissuesegmentation variables so that a plurality or all of the cutting wires122, 124 complete tissue segmentation cuts at substantially the sametime. Completing the tissue segmentation cuts at substantially the sametime may help manage temperature accumulation at each wire location.

The controller 108, 708 may be configured to cause substantiallysimultaneous cut completion by switching RF power between each of thecutting wires intended to apply the RF power. This may be achieved byswitching the RF energy in a sequential algorithm for a fixed timeperiod, switching the RF energy such that the slowest rate of travelmechanism receives the most energy, to control the cutting wires 122,124 to have the same length of travel during the cuts or based on theelectrical parameters such that those cutting wires 122, 124 indicatinga different or lower impedance values or a lower length of travel duringthe same time span may receive more RF power on average than theremaining wire sets to maintain the cuts. Those skilled in the art willrecognize that, if the electrode is not travelling, the steam pocket maycollapse, resulting in a lower impedance; in contrast, if the cutting isactive, the steam pocket may increase the impedance.

Particularly when using the multiplexed approach, the inactive timeshould be limited to maintain the steam or higher impedance around thewire to sustain cutting.

Inactive time should also be limited when a first tensioning mechanismor cutting wire 122, 124 is not advancing, or not advancing as quickly,as a second tensioning mechanism or cutting wire 122, 124, such as dueto a highly calcified tissue specimen or some other means of failure(such as encountering a staple in tissue sample). In this case, thecutting wire 122, 124 or wire set that is not properly advancing may beexcluded from receiving RF power. In some embodiments, the remainingcutting wires 122, 124 or wire sets can complete the cut.

Turning now to FIG. 8, further details of a method 800 of tissuesegmentation are now described. As illustrated, the method 800 includesreceiving 802 a plurality of tissue segmentation variables. The tissuesegmentation variables may be associated with a tissue segmentationprocedure being performed, such as segmenting a large tissue specimenprior to removal through a small incision site. The tissue segmentationvariables may include variables applied to a tissue specimen by a tissuesegmentation wire, such as energy, power, voltage, current, mechanicalforce, and/or feedback variables such as impedance, resistance, rate oftravel and distance traveled.

Receiving 802 may include receiving the plurality of tissue segmentationvariables over time.

The method 800 also includes comparing 804 one or more of the tissuesegmentation variables with a respective tissue segmentation parameter,or comparing 806 one or more of the tissue segmentation variables with asecond tissue segmentation variable, and, responsive to the comparing804 or comparing 806, adjusting 808 an energy and/or segmentation forceto a tissue specimen.

The method 800 may be achieved using the device illustrated in any ofFIGS. 1-3 or otherwise described herein.

The method 800 may include comparing a detected power factor anglePFAcut variable with a short circuit power factor angle parameterPFAshort and/or an open circuit power factor angle parameter PFAopen.The power factor angle parameters PFAshort, PFAopen are described inpreceding sections of this disclosure.

Returning now to FIG. 1, the system 100 and/or method 800 may optionallyinclude a circuit check 810 having a short circuit and/or open circuitcheck. That is, in some embodiments, the system 100, controller 108,708, and/or generator 104 may be configured to send a short, small pulseof electricity at a power well below the full or operating power levelto check 810 for an electrical short or open without damaging thesegmentation wire/bag assembly. The power during the circuit check 810may be at a level of 10 Watts or less, so that an electrosurgical effectdoes not occur.

For example, in the system 100, current and voltage sensors may beprovided to give a separate real and imaginary component of the complexload impedance applied by the system 100 to the tissue. Those skilled inthe art will understand that imaginary, or reactive, components of cableimpedance may make measurement accuracy by a generator of a shortcircuit very difficult. However, by providing a system 100 or method 800in which the real and imaginary components of the complex impedance areknown, the real component may be used to provide a better measurementfor shorts, opens and intermediate impedance values. In someembodiments, the system 100 or method 800 may include a short circuitand open circuit check and/or a mechanism for a short circuit and/oropen circuit check.

The phase and amplitude of the complex load impedance may also be usedas relative comparisons as with a short circuit, the cable inductancewill be a significant contribution to the load resulting in a positivephase angle and at an open circuit the cable and system capacitance willbe a significant contribution to the load resulting in a negative phaseangle. Methods to calculate the phase include using an analog phasedetector, comparing zero cross-over points and peak amplitudes, or usingdigital sampling and software methods such as a Goertzel algorithm.

In some embodiments, the system 100 may be configured such that thepower or RF energy delivered to the tissue can be adjusted during thecut to provide controlled outcomes. For example, power variables appliedto the wire(s) 122, 124 may be monitored and adjusted as desired, usingthe first and/or second sets 120, 130 of leads, or any suitable numberof leads for monitoring and adjusting power to the wire(s) 122, 124, andany number of cutting wires 122, 124 may also be provided.

Those skilled in the art will understand that the leads 120, 130 may beconfigured to transmit digital and/or analog signals associated with thepower variables or control signals. The RF power may be amplitudemodulated to control the cut rate of travel. Using the rate of travelfeedback, the power may be adjusted to maintain a substantially constantdesired rate of travel, to maintain the rate of travel above a minimumvalue, Rmin, to ensure low temperature cutting, and/or to maintain thepower below a maximum value to reduce the power delivered at thecompletion of the cut.

In some embodiments, a force gauge may be coupled to the tensioningmechanism, and the power may be adjusted to assist the spring inmaintaining a substantially constant force and/or a force above or belowa desired threshold for suitable tissue segmentation. These methods maybe used for other means of applying the tissue segmentation force, suchas a linear actuator or manual pull.

In some embodiments, the controller 108, 708 may be a box that is set onthe generator 104 and has a separate power cord, or, in someembodiments, the controller 108, 708 may be unitary with, and acomponent of, the generator 104, as illustrated in FIG. 1 or 2, or maybe unitary with, or a component of, the electrosurgical instrument 102.The controller 108, 708 may have only the power such as RF powerconnections attached to the generator 104 or may have an additionalconnection to communicate with a generator 104, a datastore 110, theelectrosurgical instrument 102, and/or a user interface 112, asillustrated in FIG. 2. This additional communication allows informationto be transferred to and from the generator 104. This information mayinclude power and mode settings, return electrode impedance information,error information such as deviation from tissue segmentation parametersas previously described herein, storage and statistical information ofthe procedure parameters and variables, and historical statisticalinformation of the procedural parameter database.

The controller 108, 708 may also be embodied as a battery powered devicemaking it more portable and easier to use by reducing the need toduplicate AC power connections to perform the electrosurgical procedure.

The controller 108, 708 and/or generator 104 employing the controller108, 708 may have the ability to measure the current I, voltage V,and/or other variables associated with the power delivered by thegenerator 104 prior to connecting the generator 104 output to theelectrosurgical device 102. This allows the controller 108, 708 toensure that the user has selected the proper generator setting beforeapplying electrosurgical RF energy to the wire(s)/electrode(s) 122, 124,to ensure that the integrity of any coating on the wire(s)/electrode(s)122, 124 is maintained for initiation.

In some embodiments, an internal resistor or resistors, selected toensure that the proper voltage, current and power range Vmin, Vmax,Imin, Imax, Pmin, Pmax are being delivered by the generator 104, may beprovided to ensure that the integrity of any coating on thewire(s)/electrode(s) 122, 124 is maintained. In some embodiments, thecontroller 108, 708 or system 100 is configured to alert the user, torecommend corrective action, and/or to initiate a communication with thegenerator 108, 708 to change a power setting in response to adetermination that the integrity of a coating is compromised.

In some embodiments, the controller 108, 708 may have a means to applypower such as RF energy to individual tensioning mechanisms and wiresets in the electrosurgical device 102 so that the controller 108, 708may selectively and/or sequentially energize the wires 122, 124.

In some embodiments, the user may select the proper sequence through auser interface 112 with the generator 104 or controller 108, as isillustrated in FIG. 2, although those skilled in the art will recognizethat the user interface 112 may be located on or a component of theelectrosurgical device 102 and/or any other component of the system 100.That is, the user interface 112 may include one or more means forinputting, receiving, viewing, and/or manipulating how the device 102handles the tissue.

In some embodiments, the controller 108 may be configured to determine acrest factor of the generator output, and to confirm the user hasselected the proper output mode setting. In some embodiments, measuringthe RMS or average voltage (current, power) and the peak voltage(current, power) are employed to deduce the crest factor.

FIGS. 9A-B illustrate first and second portions of a flowchart of amethod 900 of tissue segmentation control. The method 900 may beachieved using the controller 108, 708 or system 100 previouslydescribed herein. In some embodiments, the method 900 includes one ormore of (a) determining 902 if a pretension force has been applied totissue, (b) determining 904 if a power applied to the tissue isacceptable, (c) determining 906 if an impedance between a wire 122, 124and the tissue is acceptable, (d) determining 908 if a voltage appliedto the tissue is acceptable, (e) determining 3010 if a current appliedto the tissue is acceptable, (f) determining 912 if a power factor angleis acceptable, (g) determining 914 if a minimum rate of travel has beenreached, (h) determining 916 if the rate of travel is acceptable, and/or(i) determining 918 if a cut has been completed.

Responsive to one or more of determining 902, 904, 906, 908, 910, 912,914, 916, 918, the method 900 may include one or more of (a) advising920 the operator to pre-tension the device 102, (b) adjusting power orsuspending power and advising operator to change the power 922, (c)discontinuing 924 power activation and alerting operator, (d)determining 926 if a short circuit exists, (e) determining 928 if anopen circuit exists, or (f) adjusting power or advising operator tochange the power 930.

The method 900 may include, responsive to determining 926 that a shortcircuit exists, discontinuing 924 power activation and alerting theoperator or adjusting power or advising operator to change the power930.

The method 900 may include, responsive to determining 928 that an opencircuit exists, discontinueing power activation and alerting theoperator 924 or adjusting the power or advising the operator to changethe power 930.

The method 900 may include requesting 932 to deliver power, applying 934power, and removing 3036 power. Applying 934 power may be responsive todetermining 902 that pretension has been applied. Removing 936 power maybe responsive to determining 918 that the cut has been completed.

FIGS. 10A-C illustrate, together, a flowchart of a method 1000 ofmultiplexed tissue segmentation control. The method 1000 may be achievedusing the controller 108, 708 or system 100 previously described herein,and may include some or all of method 900 previously described hereinapplied to each electrode X of a plurality of electrodes 1-N. The method1000 may additionally include determining 1038 if a maximum off time forany of electrodes 1-N has been reached, and, responsive to thedetermining 1038, updating 1040 X to electrode reaching maximum off timeor updating 1042 X=X+1 until all electrodes 1-N have been activated,then updating X to remaining active electrode with lowest Rtravel,and/or determining 1042 if power activation has been discontinued forall electrodes 1-N. In other words, the system 100, 200 may beconfigured such that, if one of the electrodes has reached a max offtime, then the system will use that electrode next. If no electrodeshave reached the max off time, then the system will apply power to theelectrode that is moving the slowest.

Turning now to FIG. 11, in some embodiments, various methods and systemsfor detecting a distance and velocity of travel of one or more wireelectrodes 122, 124, such as electrodes 1-N related to methods 3000,4000, are herein disclosed. In some embodiments, for example, aplurality of visual or electrical markers 1102 on one or more constantforce springs 1104 may be provided. The markers 1102 may include lines(colored, or electrically isolated) placed at uniform distances alongeach spring 1104, and, relatedly, optical or electrical sensor(s) 1106may be provided to detect or count each time a spring mark 1102 isencountered, and thereby infer the distance traveled DTravelX and/orrate of travel RTravelX. These marks may also include a larger widththat is periodically included at a different uniform distance thanpreviously described to act as a major graduation mark. This majorgraduation mark may be used as a gross distance measure and/or may beused for count correction, such as if the rate of travel RTravelXapproaches the upper limit of the ability of the device 102 or system100 to measure the rate of travel RTravelX.

In some embodiments, the spring marks 1102 are color coded or otherwisemodified verses a distance along the spring 1104, such that a colorphotosensor or other identifying means may determine a position of thecutting wire assembly ore wires 122, 124.

Similarly, in some embodiments, and as illustrated in FIG. 12, a firstRFID tag 1220 may be mounted to a first connector block 1224 such that asingle sensor (not illustrated) in segmentation instrument 102, orcontroller 108, 708 or generator 104 may determine a position of a firstcutting assembly 151 having a plurality of wires or electrodes 153, 155(see e.g. FIG. 1) during instrument operation. A second RFID tag 1222may similarly be mounted to a second connector block 1226 fordetermining a position of a second cutting assembly 160 having aplurality of wires or electrodes 157, 159 (see e.g. FIG. 1).

In some embodiments, a force gauge or wheatstone bridge-like device maybe provided to measure a deflection of a touch probe to test deflectionat the spring coil. Those skilled in the art will understand thatgreater deflection means more spring material is deflected, and in turnmeaning further travel of the electrode or wire or sets 153, 160 ofelectrodes or wires.

In some embodiments, a bearing mount for each constant force spring 1904may be provided. A measurement of the rotation of each bearing mount maybe used to determine travel distance (and rate) of each spring andelectrode or wire.

In some embodiments, a micro ‘radar’ optical measurement of eachconnector block along the axis of the connector block travel may beprovided, to visually measure how far away each connector block is fromthe measuring sensor—thereby determining the travel distance (and rate)of each spring and electrode or wire.

In some embodiments, a resistive strip or set of strips or films may beapplied in close proximity and along the travel of the tensioningmechanism. A contact may be attached to the tensioning mechanism ortensioning block near the distal end such that it is provided electricalcoupling to the resistive strip or film. As the tensioning mechanismmoves, the contact acts in a similar manner as a “wiper” on a variableresistor. By using an electrical circuit that applies a voltage crossthe end of to the resistive film and the contact, a change in resistancecan be measured that is related to the distance of travel. The rate ofresistance change can also be measured and is related to the rate oftravel.

In some embodiments, the contact and resistive strip as previouslydescribed are provided, but with a second conductive strip that is inparallel but not electrically coupled to the resistive strip. Thecontact provides an electrical coupling to both the resistive strip andthe conductive strip. In some embodiments, the electrical circuit mayapply the voltage across the fixed ends of the resistive and conductivestrips. Those skilled in the art will understand that this approach maybe modified to utilize a contact that is not directly connected to thestrip but would operate in near proximity for the duration of travel.This approach allows an electrode to apply a variable capacitance ormutual inductance that could be used to measure the distance of travelor rate of change.

The mechanical segmentation force variable Fseg may be measured by aforce gauge on the tensioning mechanism. The force gauge may be anygauge suitable for the intended purpose, including any analog, digital,or mechanical signaling mechanism. The mechanical segmentation forcevariable Fseg may be compared to a minimum mechanical segmentation forceparameter Fmin to ensure that the correct mechanical load is beingapplied to the tissue specimen. The minimum mechanical segmentationforce parameter Fmin may defined by the design specification of thetensioning mechanism force characteristics. In some embodiments, theminimum mechanical segmentation force parameter Fmin may be definedexperimentally by measuring a force associated with a desired rate oftravel of the electrode(s) at a known power level in a control tissue.

Continuing now with FIGS. 12-14, a reusable tissue segmentation device1300 may be provided. The reusable tissue segmentation device 1300 maybe configured to perform some or all of the functions previouslydescribed herein with reference to device 102 or system 100 previouslydescribed herein and the device described in Applicant's applicationPCT/US15/41407.

The device 1300 may include a proximal portion 1302 that is detachablyconnected or connectable to a distal portion 1304. A connection region1319 between the proximal portion 1302 and the distal portion 1304 maybe a block of a wire tensioning mechanism, such that a disposable lumen1303 is attached. The disposable lumen 1303 may provide a guide 1306 forone or more tensioning mechanisms having a post 1316 that connects totensioning blocks 1318 on the proximal portion 1302, and may haveconnection points to enable the distal end 1308 to connect to the activeelectrode wire connections (not illustrated). The disposable lumen 1303may also include a means 1310 to advance tensioning springs (ortensioning force mechanism) to a pre-tension position, a pre-tensionmechanism 1312 that allows the user to pre-tension the tensioningmechanisms and an introducer 1314 for placement in the incision site anda bag (see e.g. FIG. 1).

With continued reference to FIGS. 13 and 14, a method of using thedisposable lumen 1303 is now described in further detail. In someembodiments, a control 1310 may be provided to allow the springs and thetensioning blocks 1318 of a proximal portion 1302 to be advanced to adistal position. The control 1310 may be a control tab. The springs andtensioning blocks 1318 may be held in a distal position by a lockingmechanism (not illustrated) within the proximal portion 1302.

The user may connect the distal portion 1304 to the proximal portion1302 by sliding the portions 1304, 1302 together such that the post(s)1316 (see FIG. 13) in the distal portion 1304 snaps/slides/locks intoreceiving openings 1318 a of the terminal blocks 1318 at the end of thetensioning mechanisms in proximal portion 1302. This attachment may alsocause the control 1310 or control tab to slide proximally, or back awayfrom the distal portion 1304 and allow alignment of the pre-tensionmechanism control 1312 with the locking mechanism in the proximalportion 1302. The proximal and distal portions 1302, 1304 may beconfigured such that pressing the pre-tension mechanism control 1312after attachment will release the locking mechanism and pre-tension thefour tensioning mechanisms. Those skilled in the art will appreciatethat a number of different release methods may be provided.

Continuing with FIGS. 13 and 14, in some embodiments, the tensioningmechanisms 1306 may be connected to active electrode connectors (notillustrated) prior to pre-tensioning, and may be contained within theguides 1306 during pre-tensioning and cutting.

The applied force generated by the tensioning mechanism in the proximalportion 1302 may be mechanically and electrically coupled fromtensioning blocks 1318 through the posts 1316, through the alignmentblocks 1320, through the distal end 1308 and through the activeelectrode connectors. In some embodiments, all patient contact areas maybe part of a disposable lumen 1303, which may provide for simplifiedcleaning and reprocessing of the reusable portion including the proximalportion 1302.

In some embodiments, and as illustrated in FIG. 14, a reusable portion1404 or reusable portions of the segmentation device may be enclosed byor carried within a sterile bag(s) 1402 with an aseptic transferprocess. The sterile bag(s) 1402 may enclose the reusable portion(s)1404, and a disposable portion 1406 may be attached to the reusableportion(s) by the user. Access through the bag may be made through anaccess opening 1408 in the bag 1402. In some embodiments, the accessopening 1408 is open or opened behind a sleeve that can be moved,translated or folded away, and/or punctured by a feature of thedisposable portion when the user connects the disposable and reusableportions. In some embodiments, a sterile adapter is integrated into thesterile bag(s) 1402 to facilitate connection of the sterile disposableportion(s) of the device and the non-sterile reusable portion(s), whileretaining sterility in the sterile field. Those skilled in the art willreadily recognize a number of means of providing a reusable portion(s)1402 and a disposable portion(s) 1404 and enabling connection of theportions. Any and all means now known or as yet to be developed arecontemplated herein.

Some embodiments providing means for separating the reusable componentsfrom the patient contact components may include a disposable insertinside the reusable tissue segmentation device 1300. The disposableinsert may capture the wires after the cut. In some embodiments, adevice that can be easily disassembled so that the interior area thatcontains the wires after the cut can be cleaned, reassembled andre-sterilized.

Turning now to FIGS. 15-22, in some embodiments, a tissue segmentationdevice 200 may provide multi-wire tissue segmentation in a manner thatprovides a user with the ability to tension only the wire set(s) to beactivated with a power, such as radio frequency (RF) energy. Thisability may be helpful in isolating the entire power or RF energyapplication to only those wires currently involved in tissuesegmentation. Specifically, those performing tissue segmentationprocedures may find it helpful to have the ability to tension only wiresin one planar direction, for example, all “X” direction wires for theactivation of those wires, or wire sets, with the introduction of poweror RF energy. These “X” direction wires may be configured to not overlapeach other in physical space so as to reduce the likelihood of theseactive wires electrically coupling with the inactive wires. Thoseskilled in the art will readily envision a multitude of ways to make amechanism 1502 which would selectively impart tensioning force to onlythe wire(s) to be activated, or to all wires in one planar direction.

In some embodiments, constant force springs 1503 are wound around agear-like spool 1504 which can be locked into place, such as by a flangeor tab(s) 1506 prior to tensioning or power activation.

In some embodiments, and with reference to FIG. 23, a constant forcespring 2302 is provided with a notch 2304 or additional engagementfeature. A detent gate 2306 or gates can be temporarily inserted intothe engagement feature or notch 2304 so that the constant force spring2302 is configured to be temporarily maintained in an extended state.The detent gate(s) 2306 can be selectively lifted, rotated, or slid tounlock one or both of the constant force springs 2302 and enable thespring(s) 2302 to tension the wires 122, 124 or wire sets 153, 160. Insome embodiments, a slotted collar 2308 may be provided so as to enablea user to lift or disengage the gate(s) 2306, such as by rotating theslotted collar 2308. The slot(s) 2310 may be oriented such that arotational movement will translate to a linear or vertical motion at apre-selected rotational location.

In some embodiments, a plurality of detent gate(s) 2306, such as four,are provided to engage each spring 2302 of a 4-spring assembly. In someembodiments, the gates 2306 are configured to lift or raise at aspecified rotational angle of the collar 2308. In some embodiments, afirst gate 2306 a is configured to lift or disengage from a first spring2302 a before a second gate 2306 b lifts or disengages from a secondspring 2302 b. The collar 2308 may be configured to control thedisengagement in this manner.

In some embodiments, a motorized spring and/or a bivalve pneumaticinstrument may be used in place of the slots 2310 in the collar 2308.

Turning now to FIGS. 24 and 25, in some embodiments, a tissuesegmentation device may be provided with a removal bag 161, 2400. Thebag 2400 may include a flexible container 2402 substantially asdescribed in other portions of this document, and an introducer 2404 toassist in inserting the bag 161 through an incision site. In someembodiments, the introducer 2404 may include a mandrill with a distalshape that protects the wire(s)/electrode(s) from kinking. Theintroducer 2404 may be a separate component that is removed after thebag 161 is fully placed in a patient cavity, or, in some embodiments,may be an attachment to a distal end of the tissue segmentation device,and may be removed after the bag 161 is placed, or can be a featuredesigned into the distal end of the tissue segmentation device. Theintroducer 2404 may be placed into the bag 161, 2400, and the flexiblecontainer 2402 may be collapsed around the introducer 2404 and held inplace during insertion. A recessed area 2406 of the proximal end of theintroducer 2404 may be provided to allow the active electrode connectors2410 to be recessed during insertion to reduce the chance of catching onthe patient incision site.

In some embodiments, and with reference still to FIGS. 24-25, anintroducer 2404 may have a means for mechanically coupling a drawstring2405 to a semi-rigid ring around the bag opening. In some embodiments,the introducer 2404 may be withdrawn from the bag such that thedrawstring 2405 is accessible through the incision site by a user orgrasping instrument, thereby aiding user access to the drawstring 2405when exteriorization of the bag opening is desired. The means forcoupling the drawstring 2405 may be any means known to those skilled inthe art, now developed or as-yet to be developed, and may includebinding, gluing, welding, fastening (such as a screw fastener), or anyother means.

Those skilled in the art will also understand that the drawstring 2405and/or other components described herein may be made of or have asurgical steel, a flexible metallic material, a metallic coating, aflexible metallic coating, a sterile polymeric material, a spring, acoil, a memory-retaining material, and/or other materials selected forthe intended use in a surgical environment and for minimizing transferof contaminates to the patient. In some embodiments, the drawstring 2405may be configured to bias the introducer 2404 and bag 161, 2400 to aprepared-for-insertion or compressed configuration.

In some embodiments, and as illustrated in FIG. 26, a return cableintegrated with tubing to form a secure tether may be provided to enablea user to exteriorize the bag 161. In some embodiments, the removal bag161 includes a plurality of inflation areas 2604 within the bag that canbe inflated using low pressure air. These inflation areas 2604 are usedto provide rigidity to the bag opening and/or the side walls of bag 161to assist in loading the tissue specimen into the bag 161. The inflationareas 2604 may include or be coupled to a common inflation tube 2606that, along with the return electrode cable 2602, protrudes out of thepatient when the removal bag 161 is inserted to load the tissuespecimen.

In some embodiments, the return electrode cable 2602 and inflation tube2606 are mechanically attached together and mechanically supported wherethey exit the removal bag 161 such that they can be used as a means topull the bag 161 toward the incision site after the tissue specimen isloaded. After deflating the bag 161, the bag opening may be pulledthrough the incision site by pulling the return cable/inflation tubeassembly 2602, 2606 until the bag opening or a portion of the bagopening is exteriorized allowing the user to pull the remaining bagopening out of the patient. This integration of the return electrodecable 2602 and tubing 2606 may be a molded assembly, a film appliedaround both components, layered together as one assembly, tied togetheralong the length of common attachment, or can bonded using adhesive orother means.

Turning now to FIG. 27, a tissue removal bag 2700 for the system 100 maybe provided. The bag 2700 may utilize a thin layer of film 2702 thatcontains perforations 2701 to secure the electrode(s)/wire(s) to theinterior surface of the bag 2700. These perforations 2701 may bedesigned to control the release of the electrode(s)/wire(s) during thepretension step, or may be designed to partially release theelectrode(s)/wire(s) at select locations and to release theelectrode(s)/wire(s) at the remaining locations during the travel of theelectrode(s)/wire(s) during cutting. In some embodiments, theperforations 2701 may be sized/spaced to be approximately 4-5perforations per centimeter (or about 12 perforations per inch). In someembodiments, 3-4 perforations per centimeter (or about 8 perforationsper inch) may be selected. Control of the release of theelectrode(s)/wire(s) during pre-tensioning may be achieved by selectionof the perforation per length configuration, combined with the thicknessT and elasticity of the film 2702 containing the perforations 2701,along with the thickness and rigidity of the material in which theperforation layer is attached.

In addition, the width W of the dimension in which the film 2702 is notattached to the bag 2700 defines a wire channel 2707. This wire channel2707 is an important dimension related to the ability of a wire (e.g.wire 151 as illustrated, or any wire 122, 124 or electrode describedherein) to find the perforation 2701 when the tensioning force isapplied so that it creates the separation required to release theelectrode(s)/wire(s) 151, 122, 124. This width W, combined with theelasticity and/or thickness T of the material 2702, can be adjusted inaddition to the perforation per length values and patterns previouslydescribed to provide the optimal wire release performance.

In some embodiments, the width W of the wire channel 2707 for a tissueremoval bag 2700 is less than 0.5 centimeters (or less than about 0.200inches); in some embodiments, the width is less than about 1.63centimeters (or less than about 0.064 inches). Another means to helpincrease the probability of the wire 151 separating the perforations isto have multiple perforation lines 2701 in parallel to each other in thefilm 2702 so that as the wire 151 is routed in the channel 2707, thechance of finding the line of perforations 2701 is greater.

Selection of the appropriate combination of these values can provide therelease of the electrode(s)/wire(s) in a manner that advances as theelectrode(s)/wire(s) advance during cutting, and can guide theelectrode(s)/wire(s) along a perforation channel 2707, resulting in amore predictable segmentation cut. This may be accomplished with thesame perforation per length values across some or all sections havingthe perforations 2701, can be enhanced by using different perforationper length values in different sections, can be a linear, logarithmic,or other pattern of increasing or decreasing perforation per lengthvalues, or can be patterns of perforations 2701 followed by open areas2709 to enhance the separation as the electrode(s)/wire(s) travel(s).

Those skilled in the art will appreciate that as multiple wires are usedwithin the bag, intersection points are created where a wire setintended to apply power such as RF energy to the tissue crosses in closeproximity to the wire sets that are not intended to have power or RFenergy. Some amount of power will tend to couple, either capacitively,inductively or conductively, to the inactive wire sets. This can resultin cutting of unintended wire sets which can lower the current density,as the total active electrode surface area is increased, such that thedesired cutting performance is not achieve. As such, this coupling mustbe managed to avoid unintended wire set cutting.

With brief reference to FIG. 99, in some embodiments, one or moreelectrode wires 9908 may be molded in or contained in a film 9910 orportion of a bag wall 9906. FIG. 99 illustrates a top view of how someelectrode wires 9908 might be positions.

In some embodiments, the coupling can be managed electrically byproviding a higher isolation between the intended and unintended wiresets. This can be achieved by aligning the perforation portion of thechannels at the intersection points. This provides the greatest benefitfor conductive coupling and provides a higher dielectric for capacitivecoupling.

In addition to increasing the isolation, the overall amplitude of theelectric field can be reduced. This is achieved by controlling theamount of exposure the active wire has with the tissue. As the contactbetween the wire and tissue is increased, the effective impedance isreduced resulting in a lower electrical field amplitude along the wire.In addition, as the voltage on the wire sets reaches a level wherearcing begins, the arc path will preferentially be through the tissueand not to the unintended wire sets.

The coupling can be managed mechanically be providing a highermechanical load to the wire sets intended to cut verses the unintendedwire sets. This can be achieved with separate pre-tension forces, orwith different forces applied for the duration of the cutting process.If the coupling is observed between the intended and unintended wiresets, the differential force between the two wire sets will increase theseparation between the two as the intended wire set advanced through thetissue. The increased separation will reduce the amplitude of thecoupling between the two wire sets, and ultimately to an insignificantlevel.

With continued reference to FIG. 27, perforations 2701 in the bagmaterial may be used as a temporary method to secure or contain thewires until a force or force aided by temperature rise can allow therelease of the wire. Those skilled in the art will understand that ifthe material containing the perforations or attaching the wires is afilm that has a very low temperature melting point, the wire channelsmay be configured to release primarily with the temperature created formthe power or RF energy activation. In this manner, the mechanical forceis a secondary means of releasing the wires from the bag and the activeelectrode wires activated for cutting will more easily release from thechannels upon initiation.

A feature may be combined with the wires to enhance the ability of thewire sets to break away from the bag perforations. For example, the wire151 may have a wedge shape feature that is attached to the wire orTeflon tubing to cut or improve the tearing of the perforations as thewire moves through the tissue.

Some embodiments may be configured to reduce the likelihood of a cuttissue segment that is too large to remove through the incision site. Insome embodiments, multiple layers of active electrode wire sets areattached with perforations to layers of the bag.

For example, if an electrosurgical device 102 is designed to have fourtensioning mechanisms that apply power to four separate active electrodewire sets, the bag may include an outer layer, a second layer that hasthe return electrode coupled to the outer layer, and a series ofinternal layers stacked inside the bag. Each of these internal layersmay be an insulated layer with perforations running the length of thelayer that has four active electrode wire sets attached withperforations. These layers may conform to the shape of the outer layerso that they can be easily inserted into the outer layer. The layers mayalso have an opening in the bottom area of each layer so that the returnelectrode is exposed to the tissue when the internal layers are inplace. The user may attach the connectors of the active electrode wiresets from the innermost layer to the electrosurgical device 102.

The tissue segmentation may be performed as described in Applicant'sco-pending application PCT/US15/41407. When the segmentation iscompleted and the wires are removed from the layer, the layer may beremoved by the surgeon by hand, such as by pulling on the exposedportion of the inner layer and causing the perforations in of the layerto separate, allowing the film to be removed. This removal exposes thenext set of active electrode wire set connectors. A secondelectrosurgical device 102, or a device that can be reloaded to thefully extended position, can now be connected to the tissue removal bagin the same manner as previously described. Those skilled in the art canunderstand that this increases the number of segmentation cuts andreduces the chance that a large tissue segment will remain after allsegmentation steps are completed. The layers of the bag may beconstructed such that each internal layer is rotated slightly from allother layers to further reduce the likelihood of leaving a large tissuesegment after all segmentation steps are completed.

Continuing with FIG. 27, in some embodiments, the film 2702 is separatedinto a plurality of different regions, and in some embodiments, tworegions. The bottom of the bag 2700 a may include the bottom region2706, which may be a hemisphere region as illustrated, although thoseskilled in the art will understand that a box shape or any other shapemay be selected depending on the particular purpose of the bag 2700. Thesides of the bag 2700 may have the side region 2704. Due to the forcesapplied to the tissue specimen by the electrode(s)/wire(s) duringpre-tension and cutting, the force in the bottom region 2706 may be lessthan the forces in the side region 2704, thereby biasing a release ofwires from the side before a release from the bottom. To counteract thistendency, those skilled in the art will understand that it may bedesirable to provide a film 2702 having a first thickness T1 at a sideportion that is different from, such as thicker than, a second thicknessT2 at a bottom portion. It may be desirable to provide a side section ofthe film 2702 having a first pattern of perforations 2701 and a bottomsection of the film 2702 having a second pattern of perforations 2701different from the first pattern of perforations 2701.

For example, FIG. 27 illustrates an embodiment in which the bottomregion 2706 has a 0.001 inch (25.40 μm) thick film and a 12 tooth perinch (about 4.72 tooth per centimeter) perforation to provide a lowerbreak force to separate the perforations 2701. The side region 2704 mayhave a film 2702 that is about 0.0022 inches (about 55.88 μm) thick andan 8 tooth per inch (about 3.15 tooth per centimeter) perforation 2701to ensure that a slightly higher force is required to separate theperforations 2701 in the side region 2704 as compared to the bottomregion 2700 a. This embodiment takes advantage of the fact that duringmanipulation and loading of the tissue specimen, higher forces occur onthe side regions 2704 than the bottom region 2700 a, allowing a lowerperforation force to be used in the bottom region 2700 a without concernfor failure during the loading process. This configuration also takesadvantage of the higher side region force so that theelectrode(s)/wire(s) do not fully and/or prematurely release with orduring a pre-tension step. This allows the electrode(s)/wire(s) torelease during cutting such that the perforations 2701 act as a guide toalign the travel of the wires through the tissue with the perforations2701.

Other examples of perforation patterns are illustrated in FIG. 27. Insome embodiments, a method of manufacturing a retrieval bag for anelectrosurgical device may be provided. The method may include providinga flexible bag 2700 having an interior region at least partially coatedwith a film 2702, and perforating the film in a pattern, the patternconfigured to control a release pattern of at least one electrosurgicalelectrode or wire. The method may include providing a film 2702 having afirst thickness T1 on a side portion and a second thickness T2 on abottom portion, the second thickness T2 different from the firstthickness T1.

In some embodiments, providing open windows 2709, or omission of theperforation layer at desired intervals or location(s), aides in wirerelease from the bag, as illustrated in FIG. 27. These windows 2709 donot constrain the wire(s) 151, and enable direct contact between theactive electrode wire 151 and the tissue. The area(s) of perforation, orperforation walls, provide a temporary attachment of the wires 151 tomaintain alignment.

The ratio of windows 2709 to perforation walls may be adjusted orselected in a manner similar to the perforation per length value, tocontrol the force required to release the wire 151 through theperforations. In addition, because the perforation walls cover theactive electrode wire(s) 151 prior to release, the perforation walls mayprovide an isolation layer and/or the isolation layer may have theperforation walls.

Cut initiation and the early cut performance may be enhanced inembodiments having windows 2709 placed in desired locations around thetissue specimen. For example, due to the mechanical load and electricfield distribution of the wire(s) 151, the active electrode wire(s) maypreferentially begin cut initiation at a first portion of the bag sidewalls. Placing a window 2709 at or near the first portion will enhancethis initiation. Placing a wall at or near a second portion, incontrast, moves the cut initiation towards the second portion. Bycontrast, placing a perforation wall at or near the first portion mayrestrict the cut initiation at the first portion, unless the voltagecreated on the active electrode wire 151 can create an arc through theperforation wall. The windows and/or perforation walls may thus beconfigured such that a selected portion of the bag will provide thefirst portion of the tissue being cut.

That is, the cut may be controlled so as to travel from a first regionof the tissue to a second region of the tissue.

Turning now to FIG. 28, the perforations 801 or perforation walls 2883do not extend in some embodiments to the bag opening region, allowingthe proximal end of the electrode(s) or wires(s) to be easily terminatedinto connectors 2884 during manufacturing and/or to allow the user toeasily guide the wire set connector, or termination of the wire(s) tothe corresponding receptacle in the segmentation instrument or otherdevice intended to attach to the wire connectors. Having the portion ofthe electrode(s) or wire(s) not secured by the perforation walls nearthe bag opening allows the wires to freely extend away from the interiorsurface of the bag.

With brief reference to FIG. 100, a bag 10000 may include an outer bag10002 and an apron 10004 for managing placement of the wires/electrodes10006.

Turning now to FIG. 28, an “apron” or additional layer of film 2885 isprovided in the bag to protect the wires from damage during loading.This apron may be attached to the bag opening at the proximal end ornear the bag opening. The apron may be of a cylindrical shape that iscontinuous or a series of segments that extend around the circumferenceof the inside of the bag. The apron may be positioned so that the wiresand/or wire connectors are located between the apron and another featurein the bag. The apron may extend distally along the interior surface ofthe bag to a point near or beyond the perforations so that any wire notcontained by the perforations will remain beneath the apron. With theapron, the tissue will not directly contact the wires or wire connectorsand may be easier to load. The apron may also protect the wires duringloading, manipulation of the bag and exteriorization.

The apron 2885 may have one or more pouches 2881 to temporary holdproximal portions or connectors of the wire sets.

Those skilled in the art will understand that the apron may have benefitwith any feature located on the bag surface that can interfere withloading of the specimen, and/or may be a benefit to protect during theloading, manipulation, exteriorization or other procedural steps. Insome embodiments, an apron 2885 may isolate or protect an electrode orwire 151 as previously described, a mechanical member such as a wire,cable or mesh, a protrusion of the bag surface, monitoring electrodes,temperature sensors, pressure sensors, features embedded into the bag,and/or other items that are located in the bag, placed in the bag orused in proximity of the interior surface of the bag.

The apron 2885 may also be used as a containment flap 2986 (see FIG. 29)to help retain the contents of the bag after loading. The containmentflap 2986 may be sized to remain in between the loaded tissue specimenand the interior surface of the bag such that the apron does notrestrict the tissue from being loaded into the bag. The containment flapmay also be sized such that when the tissue is loaded into the bag thetissue falls, or is placed below, the distal most edge of the apron, orthe distal most edge of the containment flap may be raised above thetissue after loading is complete. As a result, the apron 2885 may beconfigured to restrict premature or unintentional removal ordisplacement of the tissue.

In some embodiments, the device 102, 200 may have a bag with a removableapron 2885. The removable apron 2885 may be selectively positionedinterior of the bag and one or more cutting electrode wires 151. Theremovable apron 2885 may be movable relative to the bag to expose thewires 151.

In some embodiments, a drawstring 2987 is provided, and may bepositioned or located at a bottom or distal edge of the containment flap2986 to enable a user to close the containment flap and thereforecapture the tissue specimen as well as contain fluids. This feature maybe beneficial where the contents of the bag are desired to be containedduring manipulation and exteriorization of the bag, such as where thetissue specimen is believed or suspected to contain cancerous cells. Thecontainment flap and drawstring may also protect the bag features duringloading of the tissue.

In some embodiments (see FIG. 29), two apron layers may be provided, afirst apron layer 2885 to protect the bag features as previouslydescribed, and a second containment flap layer 2986 that can be used tocontain the tissue specimen in a manner substantially as previouslydescribed herein.

After tissue specimen loading, the containment flap 2986 may be used toassist in exteriorizing the bag opening. Using a drawstring 2987 that iscoupled to the distal edge of the containment flap along thecircumference, pulling the drawstring through the incision site willraise the distal edge of the containment flap around the tissue specimenand draw the opening toward the incision. The drawstring may close orsubstantially close the containment flap and guide it through theincision. The bag opening may follow as it is pulled through theincision opening. When the bag has reached its intended exteriorizedposition, the bag can be secured with a semi-rigid member 2889 aroundthe opening, can be inflated to secure or can be held with othermechanical means including being held in place by an attending surgeon.The drawstring can be loosened and the containment flap can be spreadand/or cut to provide access to the bag features on the interiorsurface, such as electrode(s) and or wire(s) or wire connectors.

In some embodiments, a separate means of exteriorizing the bag can beused so that the apron 2885 can remain in place until afterexteriorization. The bag can be exteriorized by coupling a lead orsuture 2888 (see FIG. 28) to the semi-rigid member 2889 which will helpguide the bag opening toward and through the incision site. Afterexteriorization, the apron can be accessed and raised around the tissuespecimen and out of the incision site where it can be cut or have aperforation feature 2890 that will allow the user to tear it away,providing access to the bag features on the interior surface, such aselectrode(s) and/or wires(s) or wire connectors 2884. This embodimenthas the additional benefit of reducing the chance of contact of theperitoneum or incision site with portions of the apron layer that havecome in contact with the tissue specimen during loading andmanipulation. The apron may collapse somewhat within the interior bagvolume. This “curtaining” effect can cause the apron to not remain inclose proximity to the interior surface of the bag. A feature can beadded to the apron and corresponding location on the interior surface ofthe bag to help hold the distal most portion of the apron in place.

In some embodiments, and as is illustrated in FIG. 30, a feature on theapron 3085, or tabs 3092, can be provided in the bottom or distalportion of the apron. Corresponding features, slots 3093, can beprovided in a film layer added to the interior surface of the bag. Thetabs can be inserted into the slots during manufacturing to help retainthe apron close to the bag surface until the user applies a force topull the tabs out of the slots freeing the distal end of the apron.

A method to hold the distal portion of the apron against the interiorsurface of the bag is to weld or heat seal small locations around thecircumference of the bag. These welds are designed to hold the bag inplace but easily break free when the user applies a force to remove theapron. Additionally, a larger portion of the distal apron can be weldedto the interior side of the bag with perforations added to the apron toallow it to be torn away by the user.

In some embodiments (see e.g. FIG. 28), the interior surface of the bagmay have a positioning feature configured to create a location for thewire crimp connectors to reside until connection by the user. Thepositioning feature may be a pouch, fold, or pocket 2891 created in theinterior side of the bag. This pocket can be shaped to receive one ormore connectors, and/or to removably hold the connector(s) in placeuntil the connector(s) re to be used. In some embodiments, an opening inthe bottom of the pouch may be provided and sized to allow theconnector(s) to be placed through the opening but not to allow theconnector(s) to unintentionally fall back through the opening.

In some embodiments, the bag has a pocket with an opening on the top anda slot along the side so that the wires can be placed in the slot andthe connector placed into the pocket.

In some embodiments, the location of the pocket is selected to alignwith the connections on the segmentation instrument to enableconnection. In some embodiments, a pouch, pouches, pocket, or pocketsare placed slightly below the proximal bag opening such that they remainunder the apron to protect the connectors during insertion of the bag,loading of the tissue specimen and/or exteriorization.

One advantage of the apron is that it keeps the wires and connectors outof the way during loading. Multiple and different aprons might be usedto cover different wire sets where one apron can be removed first toexpose one or more connectors for connection to the instrument before asecond apron is removed to expose one or more other connectors. Inanother embodiment, one apron may have openings for the wireconnector(s) to allow connection to the instrument while keeping thewires out of the way and avoid inadvertent wire tangling. In thisembodiment one or more first aprons with the connector openings maycover the wires while still allowing access to the connectors, while oneor more second aprons could be used for the primary purpose ofprotecting the connectors prior to connection with the instrument.

The bag may include an additional guide that contains common sets ofwires so that they maintain alignment near the bag opening above theperforations. The guide may include a heat shrink, tubing and/or othermeans to hold wires that are crimped or attached together in a commonwire connector in close proximity. One or more guides may be used atlocations along the wire(s) in which the wires can perform as intendedif they are held together, such as above the perforations at a locationnear the wire connector.

With brief reference to FIG. 98, in some embodiments, a guide lumen 9802may be provided for controlling relative placement of a wire set 9810having a plurality of wires 9804, 9805 or electrodes. A proximal end ofthe guide lumen 9802 may be coupled to or unitary with a connector 9808for attaching the wire set 9810 to the rest of the device 102 (see e.g.FIG. 1). The guide lumen 9802 may be flexible or relatively stiff insome embodiments. In some embodiments, an isolation zone for electrodewires may be provided by an isolating coating 9806 or material. Theisolating coating 9806 or material may be configured to bias the wireelectrodes 9804, 9805 away from each other, so that the wires 9804, 9805are more suitably spaced when positioned about a tissue specimen.

The guide may extend from a position proximal the bag opening towardsthe point at which the wires need to separate to be routed to theircorresponding wire channels. This distal termination of the guide shouldbe selected to not create undo tension of the wire so that it willnaturally remain in close proximity to the bag inner surface as it exitsthe wire channels and also should not interfere with the tissue loadingor the process of applying pre-tension to the tissue while advancing theintroducer tube.

Some embodiments for guiding the wires near the bag opening may includean extended wire channel. This may be used independently or inconjunction with the heat shrink or other means of capturing the wiresas previously described. The extended wire channel may be comprised oftwo polyurethane films that create narrow channels for the wires to beplaced in during manufacturing. The films may be extensions of the wirechannels attached to the inner surface of the bag and they may beattached or not attached to the inside surface of the bag above theperforations.

In some embodiments, a common film that is attached to the side wall ofthe bag up to the height of the maximum tissue specimen and free of theinner surface of the bag above this location may be provided. Theconnector(s) may be pulled out of the bag for ease of connection to thesegmentation instrument, while still maintaining containment of thewires between the wire connector and the wire channels on the bag.

In some embodiments, the two film layers are attached together by RFsealing, welding, and/or any other means to form a lumen wherecontainment is desired. In some embodiments, perforations are providedto allow the wires to be released from the guide by the user. The filmscan also be designed with a thin inside film layer such that the usercan “tear” the wires through the film prior to applying the pre-tension,thereby allowing unrestricted travel of the pre-tension introducer tubeinto the incision site in preparation for the cutting procedure.

In some embodiments, an extended wire channel is located underneath anapron, with the proximal termination near the connector temporarilyattached to the inner surface of the bag. This attachment may be with aheat sealed connection that is designed with a perforation for the userto tear away when making the wire connection, may be a thin film suchthat the user can “tear” the extended wire channels away from the innersurface of the bag, may be attached with a slot in the side of the bagin which the extended wire channel is seated during manufacturing,and/or other methods of attaching this channel to the inner surface ofthe bag. In some embodiments, the attachment may be made with the wireconnector by the use of a pouch or region of the bag near the opening inwhich the connector is placed during manufacturing in which the user canremove during wire connection.

The shape of the extended wire channels can be designed or configured toreduce the chance of twisting the wires when released from inside thebag. In some embodiments, a relatively wider extended channel may beprovided. In some embodiments, a plurality of wire channels are providedand aligned in parallel on the same extended wire channel. The width ofthis extended wire channel resists the twisting of the wires as the usermakes the connections. In some embodiments, Mylar strips or othermaterial is attached to the wire channel film to enhance this anti-twistfeature. In some embodiments, Mylar strips or other material is placedbetween the outer layer and a third layer of film so that the extendedwire channel naturally stays aligned in the proper position.

Some embodiments provide separate channels within the segmentationinstrument. For example, a tray that also aligns the tensioningmechanism during cutting may provide separate channels. Keeping thedifferent wire sets separate within the instrument eliminates potentialtangling or interfering with each of the different wire sets as they aretensioned and as the cut progresses.

The guide structures previously described become particularly importantif the wire length is designed to allow a long separation of the wireconnector to the specimen bag after exteriorization, or if theconnections are fixed to the tensioning mechanism such as described inApplicant's co-pending U.S. patent application Ser. No. 14/805,358, thecontents of which are incorporated herein by reference in theirentirety.

In some embodiments, the return electrode cable extends from the distalportion, or bottom, of the specimen bag along the inner side wall of thebag and out of the bag opening. A means to ensure that the returnelectrode cable does not interfere with the wire sets is important toensure unabated cutting. This return electrode cable can be separatedfrom the wire sets by routing the cable in a location between wire setsunder a return electrode cable “wire channel” composed of a polyurethanefilm in a similar manner as the wire channels that contain the wire setchannels by bonding the cable to the inner side wall, or can be routedbetween layers of the polyurethane film or can be created by depositingconductive material on the bag surface with an insulation layer added toensure electrical isolation.

The segmentation instrument may include an indication on the exteriorsurface that visually aligns the orientation of the instrument to aspecific feature on exteriorized portion of the specimen bag. Thisallows the user to keep proper alignment during connection of thespecimen bag wire connectors to the segmentation instrument. Thealignment feature can be a label, an inserted feature, an overmoldedfeature, a molded feature in the housing, a silkscreened shape, a shapewith a similar color, a registration number or other symbol or othermeans of identifying to the user. Some embodiments may include acontrasting line applied axially to the exterior housing of the distaltube such that when the line placed in alignment with the returnelectrode cable, the instrument is in proper alignment with the specimenbag for wire connections to be made.

With the introducer tube extended into the specimen bag and against thetissue specimen, any slack within the wires is removed and a tension isapplied to all of the wire sets. This tension aligns the wires from thedistal end of the introducer tube to the wire connection point insidethe segmentation instrument. This alignment ensures that each wire setcan advance within the instrument without interfering with the otherwire sets. Without this alignment, the chance of a non-activated wireset catching or tangling with the wire set being cut increases.

Turning now to FIG. 31, a retrieval bag 3130 may be provided for thesystem 100, and the bag 3130 may include an inflatable feature.Inflation of the bag 3130 may be achieved using a honeycomb pattern ofinflated or inflatable cells 3132. A plurality of inflatable cells 3132may provide a thermal barrier between the patient and theelectrode(s)/wire(s) inside the bag 3130. If the inner layer ispunctured or thermally fails, the cell(s) 3132 would collapse leavingthe remaining cells 3132 intact, to continue to provide thermalprotection. In some embodiments, the cells 3132 may include a pluralityof inflation channels 3132, some or all with a separate means to holdthe pressure such as a separate syringe or stopcock. In someembodiments, the bag 3130 may include small independent areas that havestatic air captured under pressure.

The inflated cells 3132 provide an additional thermal insulation barrierbetween the tissue specimen or electrode and the adjacent structuresoutside of the exterior surface of the removal bag. In contrast, if theentire bag is inflated as a single cell, failure of one of the layerswould cause the inflation and thermal insulation to be lost. Byproviding multiple independent inflation areas 3132 in the bag 3130, ifone of the layers in an individual region fails, the thermal insulationof that layer may be lost or reduced; however, the remaining inflationcells 3132 will continue to provide thermal insulation, and minimize anythermal damage caused to the patient.

With continued reference to FIG. 31, a removal bag 3130 with multipleinflation areas 3134 (labeled 1, 2, 3, 4), each with a separate sourceof pressure or with a separate means to hold the pressure, may beprovided. Those skilled in the art will understand that any number ofinflation areas 3134 may be provided, and that the same or fewer meansto inflate may be provided. For example, a first inflation area 3133 maybe fluidly coupled to a second inflation area 3135 such that a singlepressurizing source 1 may pressurize both areas 3133, 3135.

In some embodiments, inflation features or functions are integratedwithin the wire channels. For example, a third layer may be provided atthe channels. The first layer is the perforation layer, the second is aboundary layer and third is a bottom layer. The boundary layer andbottom layer are sealed so that when low pressure air or fluid inapplied, the channel will inflate providing structure directly beneaththe wire channels. This has a benefit in providing thermal insulationdirectly beneath the wire as well as helps provide structure which aidesin release of the wire from the channels.

Turning now to FIG. 32, some embodiments for tissue segmentation includeusing ultrasonic energy to provide a vibratory motion to theelectrode(s) or wire(s) in combination with or independent of a voltageand current applied to the tissue through the electrode(s) or wire(s).As previously described, the mechanical load F (see also FIG. 2) on thewire 122, 124 is critical, and may be a constant force, or may beapplied dynamically. Dynamic loading may include use of vibrations wherea transducer may be used to generate high frequency vibrations on thewire or wire ends. Using ultrasonics to create the vibrations may beused alone or with RF energy. In some embodiments, the ultrasonictransducer is on the segmentation instrument. When the wire connectorson the bag are connected to the segmentation instrument ultrasonic orhigh frequency vibrations are transmitted to the wires in the bag whilethe wires are pulled through the specimen using a spring or alternativemeans to apply the force.

In some embodiments, a piezoelectric crystal or piezoelectric stack ofcrystals 3202 is coupled to an end of the tensioning mechanism 3204which may include a spring 3206 or other means of applying a mechanicalload. As illustrated, an active electrode wire 3208 may be mechanicallyconnected on an arm 3212 that vibrates perpendicularly to the tensioningmechanism 3204. The vibrating arm 3212 may be acoustically coupled tothe piezoelectric crystal 3202. The crystal 3202 may use an ultrasonichorn 3214 or coupling to amplify the displacement, and may be orientedsuch that torsional motion in the ultrasonic range causes vibrationaxially or longitudinally along the electrode(s) or wire(s).

A control system may be applied to the electrodes of the piezoelectriccrystal to drive the oscillation at the optimal frequency. The controlsystem may utilize a phase-locked-loop to control to an optimizedfrequency that provides the highest ultrasonic power transfer throughthe wire and into the tissue. The phase-locked-loop may also have anamplitude modulated gain stage designed to maintain oscillation from thelowest force applied to the highest force applied by the tensioningdevice. Other control systems may be utilized such as a Wein-bridgeoscillator or a fixed oscillation that does not maintain constantdisplacement used as a compliment to RF energy cutting.

In some embodiments, an introducer (see FIG. 5) may act as a protectivesleeve for the incision site. In some embodiments, and with referenceagain to FIG. 32, one side of the electrode/wire 3217 is terminated in afixed position 3216 on the tensioning mechanism 3204, and the other sideof the wire 3217 is connected to the vibrating portion of thepiezoelectric crystal 3202. The wire 3217 therefore is configured toexpand and contract, and allow a tissue segmentation to occur with theagitation and frictional thermal response of the wire 3217 to tissueinterface. The wire(s) 3217 may be configured to capture the entirespecimen and cut the large segments, or may be configured to cut smallerportions of the tissue specimen that would be removed as a smallertissue segment, in some cases in a similar manner as a mechanicalmorcellator.

Turning now to FIG. 33, a tissue segmentation device 102, 200 (see e.g.FIG. 1 or FIG. 2) may be provided, having one or more wire electrodes3302 and a tissue removal bag 3304. The wire electrodes 3302 may becoupled to the tissue removal bag 3304 by embedding the wire electrodes3302 into a film 3306 on an interior of the removal bag 3304. A tissuecutting effect may be initialized by applying power to the wireelectrode 3302, causing the film 3306 to break down, whereby the wireelectrode 3302 is released from the bag and a spark between the tissueand the wire electrode 3302 is initiated to achieve the tissue cuttingeffect.

Those skilled in the art will understand generally that initiation ofthe wire to begin the cutting effect results from a separation betweenthe wire electrode 3302 and the tissue when power such as RF energy isapplied, and that coating on the wire electrode or a film material inthe bag 3304 or any other component may be suitable for achieving thiseffect.

In some embodiments, a separate means to pre-tension the tissue sampleand an insulative layer between the wire electrode 3302 and the tissueare provided for this purpose. This layer may be a pressurized airlayer, a non-conductive fluid layer, an insulating film or layer appliedbetween the wire and tissue, which may serve the alternative function ofapplying the tension of the tissue sample, or could be achieved with thedesign of the bag, the wire attachment, and the pre-tension mechanismsuch that a gap results in the tissue wire/bag interface duringoperation. The desired wire set to be activated may have power such asRF energy applied and after sufficient power having a voltage isapplied, the wire set may either be pulled to the surface of the tissueor may mechanically, electrically or with temperature break through theseparation layer and begin the cutting effect. Generally stated, anyeasily electrically removable (or degradable) adhesive or retainingvolume to hold the wire electrode in place may be provided, asillustrated in FIG. 33. Upon electrical input, the bare wire electrode3302 will cut through the retaining medium (adhesive/retaining volume)or film 3306. This easy to degrade medium or film 3306 may also providea pseudo air-gap, to promote initiation of the tissue cutting effect.

Turning now to FIG. 34, a return electrode 3420 that has is attached tothe bag and contains extensions 3421 longitudinally down the bag sidewalls. These extensions 3421 are located in-between the active electrodechannels 3422, and are electrically connected using a ring 3423 at thedistal portion of the bag side walls. In the illustrated configuration,the wires 151 only cross over the return electrode 3420 at the ring3423; those skilled in the art will therefore recognize that the returnelectrode 3420 should be isolated from the wires 151 at the ring 3423,such as by a film 802 as previously described herein. The isolationrequired to insulate the active electrode/wires 151 from the returnelectrode 3420 is reduced in the illustrated embodiment by the use ofthe extensions 3421. That is, in some embodiments, the device 102 orsystem 200 may include a plurality of electrically conductive elongatedportions or extensions 3421 coupled to a base or ring portion 3421. Inaddition, this configuration provided the lowest observed impedanceoccurring at the beginning of the cut (e.g. near the bottom of the bagor ring 3421). As the wire 151 travels into the tissue, the impedancewill slightly increase providing more energy to sustain the cut as thewire travels away from the return electrode 3420.

One additional advantage of the return electrode 3420 is that the bagassembly will more easily compress to a small diameter to aide ininsertion through the incision site.

In some embodiments, and as is illustrated in FIG. 35, the returnelectrode 3540 may include areas for the return electrode 3540 to befolded or collapsed, to aid in insertion through the incision site. Forexample, the return electrode 3540 may be a dual return electrode 3540,having a first return portion 3544 and a second return portion 3546,which are attached to the inside surface of the distal portion of thebag. The portions 3544, 3546 may have recessed areas 3542 that allow theextensions 3548 to collapse, similar to an umbrella. At least a portionof the extensions 3548 may have a pie shape, or taper between a widedistal portion towards a narrow proximal portion, relative to a centerof the return electrode 3540. In some embodiments, a first portion 3544of the dual return electrode 3540 has about 5 extensions 3548, and asecond portion 3546 of the dual return electrode 3540 has about 5extensions 3548. In some embodiments, the first and second portions3544, 3546 mirror one another.

The dual return electrode 3540 may be configured to collapse against theintroducer allowing easier insertion, while providing a large surfacearea 3549 when the tissue is loaded and tension is applied to the bag.Those skilled in the art can see that the number of recessed areas 3542and the ratio of return electrode surface area 3549 to recessed areas3542 can be adjusted to ensure the surface area 3549 remains largeenough to maintain lower return electrode heating during poweractivation, and ease of collapsing during insertion of the bag into theincision site.

Methods of making a return electrode such as those described herein mayinclude bonding a return electrode and cable to the bag, or forming theelectrode on the surface of the bag with a vapor deposition, spraycoating or a conductive printing process. A deposition or conductiveprinting method may provide improved flexibility of the finished bag toallow easier insertion. Bonded return electrodes and return electrodecables may be made from flexible circuits bonded with adhesive, or maybe integrated into the bag layers by heat sealing at the boundary of thecable and/or return electrode.

In some embodiments (not illustrated) tissue segments may be marked foridentification through the use of power modulation of each wire or wireset, such as providing a different power setting or waveform so as toleave a characteristic desiccation layer or pattern as part of thesegmentation cut. This different power setting or waveform may be amodulated higher frequency waveform that is combined with thefundamental waveform delivering the RF power to the tissue. As such, theprimary function of controlling the RF power delivered to the tissue toperform the cut can be relatively unaffected by the modulated waveformby the use of an analog or digital low pass or band pass filter in thecontrol system feedback loop. That is, the method 10000 may includeadjusting a power setting so as to cause the wire to leave anidentification pattern in the cut associated with each of wires 1-N. Insome embodiments, the identification pattern may be different for eachwire, or some wires may have the same identification pattern as others(e.g. some may simply identify a direction, or which wire was the firstor last, etc.).

Turning now to FIG. 36, the electrodes/wires may have a color codedpowder applied to the surfaces such that each electrode/wire has adifferent color, and the distal end of the tissue specimen becomesmarked when the wires are pre-tensioned against the tissue specimen. Forexample, a first wire 1 may have a powder coating having the color A,and a second wire 2 may have a powder coating having the color B. Theresulting markings on the tissue specimen may be used to recreate theorientation of pieces of the segmented tissue specimen.

With reference now to FIG. 37, in some embodiments, the electrodes orwires may be provided with insulation sections or highly conductivesections that provide a “signature” or orientation mark on therespective tissue cutting edge as the wire travels through the tissuespecimen. For example, as illustrated in FIG. 37, a coating 3702 may beapplied to a first active electrode 3712 to define an active electrodesurface area. Within the active electrode surface area may be two bandsof insulation material 3704 that are less conductive for the power or RFenergy than the surrounding area. As a result, the current concentrationis less at the interface of the tissue and the insulation material 3704.This results in a visual difference in the desiccation of the tissuespecimen after the cut. The surface of the tissue will have linescreated by these insulation bands 3704 that can be used to identifywhich tissue segment was cut by the first active electrode 3712. Thesebands 3704 may be repeated throughout the first active electrode 3712 toleave this pattern across the entire cutting plane.

With continued reference to FIG. 37, a second active electrode 3714 mayhave a plurality of bands of insulation material 3704, in a number thatis different from that of the first active electrode 3712; a thirdactive electrode 3716 may have a plurality of bands of insulationmaterial 3704, in a number that is different from that of the firstactive electrode 3712 and the second active electrode 3714. More orfewer electrodes may be provided, having bands 3704 in any suitablepattern to distinguish the segment planes cut from each active electrode3712, 3714, 3716 from the others.

In some embodiments, a first ring of material 1006 may have alongitudinal dimension that is different from a second ring of material3708. In some embodiments, the first and second rings of material 1006,3708 have a conductivity that is different from the rest of the coating3702 on the electrode 3716. In some embodiments, the rings of material1006, 3708 are more conductive than the rest of the coating 3702. Insome embodiments, the rings of material 1006, 3708 are less conductive.In some embodiments, the first ring 1006 has an overall surface areathat is different from an overall surface area of the second ring 3708.

In some embodiments, the length of the insulation material 3704, thenumber of bands for a given length, and/or the spacing of the bands 3704may be modulated so as to sufficiently identify cuts made by therespective active electrodes. In some embodiments, the bands may,instead of an insulating material, have a highly conductive materialthat conducts current at a higher rate than the normal coating 3702 onthe active electrode surface. That is, generally speaking, theidentification bands 3704 may be more or less conductive than thecoating 3702.

In a tissue segmentation method, a surgeon may pre-mark the tissuespecimen during loading or after the bag is exteriorized.

In some embodiments, an ink stamp may be provided on the proximal tissuespecimen surface when the bag is exteriorized, can be an ink stampmarked during loading, or can be dyes injected into regions of interestinto the specimen prior to cutting.

Returning briefly to FIG. 1, in some embodiments, a removal bag 161 thatcontains multiple sets of active electrode wires 153, 155, 157, 159 maybe provided. The bag 161 and active electrode wires 153, 155, 157, 159may be designed to have a specific sequence of activations of the wires153, 155, 157, 159 to avoid interference between a first wire set and asecond wire set. To prevent a user from performing the power or RFenergy activations in an incorrect sequence, connectors may be colorcoded or shaped to correspond with the tensioning mechanism connections.Relatedly, the tensioning mechanisms may have a predefined sequence ofoperation that the user or controller selects.

The receptacle of the tensioning mechanism designed to connect to theactive electrode wire connector may have a color or shape associatedwith it. The corresponding active electrode wire connector may have thesame color or shape allowing the user to connect the like colors or likeshapes together ensuring that the proper sequence will be maintained. Insome embodiments, a method of ensuring the proper connection sequence ismaintained includes providing each of the tensioning rod receptacleswith a unique shape such that it will accept only the correspondingactive electrode wire connector having a unique mating shape.Alternatively the respective wires may have increasing amounts ofcoating impedance from one wire to the next. Energy may then be appliedto all of the wires, however the coating variation will force the wiresto fire or cut sequentially rather than simultaneously.

In some embodiments, the spring 676 is used as a direct electricalconductor to apply the power or RF energy to the wires, and insulationcoatings may be applied to the surface of the spring to control whenpower application can be enabled. Locations of this insulation materialcan be applied so that when the spring is in the fully extended, orpre-tension, position an insulation coating is located at the contactpoint of the power or RF energy to spring electrical interface. When thedevice is pre-tensioned and the springs advance to apply the tension onthe tissue sample, the insulation coating advances to the coil of thespring and an electrically conductive portion of the spring is now incontact with the RF to spring electrical interface. An additionalinsulation coating can be applied at the location in which the springcompletes its cut so that power or RF energy is terminated.

Some organs for specimen cutting include but are not limited to: uterus,ovary, kidney, colon, spleen, liver, gallbladder, and lung. For someorgans, the minimally invasive access and excision of the specimen maybenefit from a noncircular distal instrument end such as in videoassisted thorascopic surgical procedures (VATS) for lung. In this casethe incision may be much wider than it can be tall because of spacingbetween the ribs. In this case it may be advantageous for thesegmentation instrument to be non-circular to accommodate or optimizeuse of the space available. For example, more than two tensioningmechanisms may be generally arranged in a line within an oblong ovalshaped instrument end. The shape of the bag may also be modified tobetter align the electrode wire assemblies with the tissue specimenshape and size. This may also require a different number of activeelectrode assemblies or different active electrode wire lengths.

In some procedures, it is likely that the specimen may contain a stapleline or clip remaining from an excision. This is particularly common inlung and colon procedures. It may be desirable to utilize a strongerwire that is more likely to penetrate the staple line during the cutwithout breaking the active electrode. This may be accomplished throughuse of a stronger material, titanium as an example. It may also beaccomplished through the use of a stranded wire or a larger diameterwire than would be typically used.

As technology advances and drives more minimally invasive procedures,the incision sizes commonly used in surgery continues to reduce. Asthese sizes become smaller, the need to remove tissue specimens that areroutinely removed with currently available methods becomes more of achallenge. In addition to the organs previously mentioned that arecandidates for specimen cutting for removal, smaller portions of theseorgans and small masses that are not considered necessary for tissuesegmentation prior to removal will become candidates for removal in thefuture. An example could be an appendix or gall bladder that can easilybe removed through a 5 mm trocar today, but as the use of 3 mm devicesor smaller become more commonplace, segmentation of the device willbecome an obvious solution for removal.

In some embodiments, a crimp connector including a resistor, opticalfeedback or RFID that that has corresponding circuit in the tissuesegmentation device 100 or the controller 108, 708 may be provided thatmay perform an identification method. In some embodiments, theidentification method includes: (a) identify to the controller aparticular length of exposure, to notify the controller of proper powersetting (controller can adjust if different length exposures are used);and/or (b) identify to the controller the type of bag being used. Theidentification method may include distinguishing or identifying the useof a small uterine bag, a large uterine bag, a lung bag, a colon bag, akidney bag, etc. The bag identification method may be achieved using theresistor value, optical signature or RFID as an index for a lookup tablepre-programmed into the datastore 110 of the controller 108 or device102. The index may point to stored parameters that update the parametersfor the particular type of bag or the specific active electrode wire setconnected to the connector containing the resistor. In some embodiments,the information programmed in the optical encryption or in the RFIDcontents is used to update the parameters with the information passed tothe controller 108. This information may, in some embodiments, includethe sequence number so that the controller is configured to apply RFenergy in the correct sequence for any connection made by the user ormay contain impedance or other performance information that can be usedas an adjustment to parameters for that particular active electrode wireset.

Turning now to FIGS. 38 and 39, some embodiments may include a resistor3800, 3901 integrated into the crimp connector 3905 to provide aresistive value that can be used to provide information regarding theactive electrode wire set. FIG. 38 illustrates an example of theresistor 3801 with a resistive element 3802 and contacts or end caps3803. The resistive element 3802 provides the desired resistance and canbe a carbon, film or wire wound material. The contacts or end caps 3803are composed of a highly conductive material, such as tinned copper oraluminum, and are attached to the resistive element such that thedesired resistance provided by resistive element 3802 can beelectrically measured between the two contacts 3803.

FIG. 39 illustrates an embodiment that integrates a resistor 3901 intothe crimp connector 3905 and crimp ferrule 3906. The crimp ferrule 3906contains the termination of the common active electrode wires 3907intended to be mechanically and electrically coupled. These wires 3907fit through a lumen in crimp ferrule 3906 and are crimped to secure thewires mechanically, as well as to provide electrical coupling betweenthe active electrode wires 3907 and the crimp ferrule 3905. Thoseskilled in the art will recognize that these wires can be welded, bondedor captured within the crimp ferrule with means other than crimping aslong as the method provides an electrical coupling from the wires 3907to the crimp ferrule 3906.

In some embodiments, the crimp ferrule 3906 has a stepped feature at aproximal end such that the crimp ferrule 3906 is fixed in or relative tothe crimp connector 3905. This provides mechanical and electricalcoupling between the crimp ferrule 3906 and the crimp connector 3905.The resistor 3901 may be placed within the crimp connector 3905 suchthat the distal end cap 3909 is electrically in contact with the endcrimp ferrule 3906. This provides an electrical coupling from the outersurface of the crimp connector 3905 to one end of the resistor 3901.

Of note, the proximal end cap 3910 is electrically isolated from thecrimp connector 3905. This is achieved by creating an isolation barrier3908 that may be provided by, for example, an insulative film betweenthe resistor 3901 body and the internal surface of the crimp connector3901. This may be an insulative film or coating applied to the topportion of the inside surface of the crimp connector, an insulative filmor coating applied to the sides of the end caps 503, physical separationprovided with end caps that have a smaller diameter than the resistiveelement or by placing the resistor within an insulation component thatexposes only the center of the top end cap prior to inserting into thecrimp connector.

In some embodiments, a resistance value of resistor 3901 can beelectrically measured between the proximal end cap 3910 and the outersurface of the crimp connector 3905.

With continued reference to FIG. 39, the component within the tensioninginstrument that interfaces to the crimp connector has a center axialcomponent (not shown) that is electrically isolated from the outerportion. The axial component may have a spring or other means ofensuring contact when the crimp connector 505 is placed into thetensioning instrument. The resistance of the resistor 501 is thenmeasured by applying a known voltage or current between the center axialcomponent and the outer portion contacting the remaining surface of thecrimp connector 505 and measuring the resulting other one of current, orvoltage.

Turning now to FIG. 40, in some embodiments, a resistive element 4020may include a coating or ring of material at the proximal end of thecrimp connector 4021. This resistive element 4020 can be applied byspraying, vapor deposition, machined and bonded in place or with othermeans. As previously described with reference to FIG. 39, an electricalcoupling from the wires 4007 to the crimp ferrule 4006 may be provided.

Here, the component (not shown) within the tensioning instrument thatinterfaces to the crimp connector 4021 has a separate contact point onthe inside mating surface at the proximal end and must be electricallyisolated from the lower portion. The resistance of the resistor 4020 isthen measured by applying a known voltage, or current, between theproximal contact point and the outer portion which contacts theremaining surface of the crimp connector and measuring the resultingother one of current, or voltage.

Measuring the resistance can be achieved using an analog circuit, suchas an op amp or other means to apply the reference voltage or currentand an A/D converter to measure the resulting electrical parameter. Thiscircuit can be located within the tensioning instrument or can belocated within the controller.

Separate electrical traces may be provided to each side of the resistor501, 4020 and may be accomplished by applying a thin conductive trace onthe surface of the spring isolated from the spring with an isolationfilm. The conductive trace may be routed to either the axial contact(see FIG. 39), or the proximal contact (see FIG. 40) by a terminationblock that connects the tensioning rod to the spring at the distal endof the device. At the proximal end of the spring, separate springcontacts located at the coil of the spring align with the conductivetrace and the remaining spring surface.

In some embodiments, the electrical traces are provided by usingseparate contact areas on outer surface of the termination block thatare routed to either the axial contact illustrated in FIG. 39 or theproximal contact illustrated in FIG. 40. When the crimp connectors 4006are attached, the instrument is in the fully extended position. In thisposition, spring contacts located in the housing of the instrument canbe aligned with the contact areas of the termination block to make theresistor measurement prior to applying pre-tension of the instrument. Insome embodiments, the resistor value measured for each crimp connectoris stored in a datastore, which may be located on either the tensioninginstrument or in the controller itself.

Returning now to FIG. 1, in some embodiments, a system 100 having a bag161 may be provided. The bag 161 may have a plurality of activeelectrode sets 153, 155, 157, 159, each having a resistor (notillustrated). The first electrode set 153 may have a resistor having afirst resistance, such as 100 ohms. The second electrode set 155 mayhave a resistor having a second resistance, such as 200 ohms, the thirdelectrode set 157 may have a resistor having a third resistance, such as300 ohms, and the fourth electrode set 159 may have a resistor having afourth resistance, such as 400 ohms. The controller 108, 708 may detecteach resistor value and apply RF activation to the electrode sets 153,155, 157, 159 according to a particular sequence. In some embodiments,power is applied to the first electrode set 153 first, the secondelectrode set 155 second, and so on, regardless of which tensioningmechanism in which they were connected.

A second type of bag also with 4 active electrode wire sets may contain1100 ohm, 1200 ohm, 1300 ohm and 1400 ohm resistors respectively. Usingthis approach, those skilled in the art can see that many number of bagtypes with varying combinations can be supported with a controller thatcontains the lookup table information.

In some embodiments, the system is configured to perform a tissue toreturn interface impedance check. Those skilled in the art willunderstand that it is essential to have good contact between the tissuespecimen and return electrode of the device to maintain low temperaturecutting. One method to ensure this contact is described in the opencircuit check previously described herein. Another method is to utilizetwo sections of the return electrode in a manner similar to methodsknown in the art. Using known methods, a small interrogation signal isapplied by the electrosurgical generator between two sections of thereturn electrode. This signal is used by many currently availablegenerators to calculate the impedance between the two return electrodesections. As the tissue makes contact with the two sectionssimultaneously, the impedance of the tissue between the sections willprovide a low resistance. This is continuously monitored by thegenerator, and if the tissue loses contact with the return electrode,the impedance change can be observed and an alarm condition can beinitiated so that the user can address the situation.

In some embodiments, a movement/position indicator is provided.Graduated markings on the surface of the spring in conjunction with anoptical encoder or transceiver pair allows relative measurement ofspring travel. A rate of electrode/wire travel may be detected byintegrating over a time period a length of travel. The length of travelmay be determined by counting markings from a pre-tension location. Astopped travel condition may be identified and indicated by a lower thanacceptable rate of travel.

Turning now to FIG. 41, a method 4100 of active electrode connectorrecognition is disclosed as illustrated. The method 4100 may include oneor more of (a) connecting 4102 active electrode to tensioning mechanism,(b) reading 4104 a resistance value, (c) determining 4106 if theresistance value has a corresponding lookup table index, (d) determining4108 if the active electrode index value is consistent with otherconnections previously made, (e) determining 4110 if all expected activeelectrodes have been connected based on the index value, (f) updatingparameters 4112, and (g) alerting the operator 4114.

Applicant has determined that as the tissue is segmented with multiplepower or RF energy activations of the system 100, the structure of thetissue is weakened and the tissue “flows” or changes shape, which cancause irregular or non-repeatable segment sizes to occur. A method ofreducing this tissue flow may be provided, and may include holding thetissue during segmentation to contain the flow.

For example, and with reference to FIG. 42 and FIG. 43, inflation may beprovided at specific areas to hold the tissue in place.

FIG. 42 illustrates a top view and a side view of a removal bag 4200having four separate active electrode wire sets 4202. The bag 4200 alsoincludes inflatable channels 4204 that run parallel to the wire sets andare located on the bag surface in-between the wires. These inflatablechannels 4204 are deflated when the tissue specimen is loaded andinflated after the bag 4200 is exteriorized and connected to theelectrosurgical device 102. The inflation causes the inflation channels4204 on the bag 4200 to extend to contact a surface of the tissuespecimen and provide support around the circumference of the bag 4200.The tensioning mechanisms are then pre-tensioned to start thesegmentation process. The location of the inflation channels 4204 may beselected to allow the active wire electrodes to contact the tissue andperform the cut without interfering with the channels 4204. The locationof the inflation channels 4204 may also support the tissue during theentire cut, thereby reducing tissue “flow”. After the cut is completed,the inflation channels 4204 may be deflated to allow specimen removal.This inflation and deflation can be performed with a syringe. In someembodiments, the controller 108 or a second device may be configured toregulate the pressure automatically. Feedback on successful pressureapplication may be provided by observing an acceptable range of volumeapplied for inflation with a syringe and the resistance of increasingthe pressure manually with an automated syringe application, or withpressure sensors in an automated pressure delivery device.

FIG. 43 illustrates a method 4300 of using a tissue removal bag fortissue support. The method 4300 may include one or more of (a) loading4302 a tissue specimen, (b) exteriorizing 4304 the bag opening, (c)connecting 4306 active electrode wire connectors to tissue segmentationdevice, (d) inflating 4308 the inflation channels to hold the tissuespecimen, (e) inserting 4310 the introducer into the patient as thepretension is applied to the tensioning mechanism(s), (f) segmentingtissue 4312 for all active electrode wire sets, and (g) deflating 4314the inflation channels.

Returning now to FIG. 41, in some embodiments, after successfulcompletion of active electrode recognition, the instrument or controllermay update the parameters as indicated in FIG. 41. As part of thisparameter update, the sequence of activation may be included. As such,the instrument or controller may automatically select the activeelectrode wire corresponding to the first pull to apply the power or RFenergy. In addition, the instrument or controller may also select thepre-tension mechanism related to the active electrode wire correspondingto the first pull. A solenoid or other electromechanical means to lockout the pre-tension mechanism until an enable signal is applied from theinstrument or controller may provide the ability for the instrument orcontroller to select the pre-tension mechanism. The pre-tensionmechanism of the first active electrode and/or the second activeelectrode may be desired to be enabled at the same time so as to assistin holding the tissue specimen before and/or during the cut.

Some methods and/or systems improve the reliability of the cut bypre-treating the tissue sample prior to cutting, such as by applyingcryo to freeze the tissue. This may provide a more rigid specimen, andmay reduce the thermal result of the cutting. Some methods includeinjecting a fixation material into the tissue specimen, which increasesthe rigidity of the specimen.

In some embodiments, a tensioning mechanism may include a constant forcespring 702 and/or other mechanisms such as a pulley system, a cabledrive or winch system, non-linear springs, linear drive with rotationalcoupling such as gears or contact coupling, linear drive with magneticcoupling, linear drive with manual control, and/or, as previouslydescribed, an electromechanical drive, such as a servo or stepper motordrive or linear actuator.

In some embodiments, a method of preparing or examining a tissuespecimen is provided. One method for marking and reassembling the tissuespecimen for later pathology involves the surgeon marking the margin orarea of interest for later pathology prior to or just after placing thespecimen in the bag. The surgeon can then segment the tissue and removethe pieces from the bag. Once removed, the specimens can be reassembledor the marked pieces may be identified and examined for pathologicassessment. The marked specimens may be identified through visualexamination or may contain a fluorescing or similar chemical marker toenable the user to identify the segments using a fluorescing light.

Turning now to FIG. 44, a specialized marking tool 4400 may be providedin some embodiments, and may be utilized by the surgeon to mark aspecimen margin or area of interest prior to segmentation. This markingtool 4400 may include a shaft 4402 configured to fit through alaparoscopic opening or trocar. In some embodiments, the shaft 4402 ofthe marking tool 4400 has a small diameter of between 2 and 20millimeters, although those skilled in the art will understand thatother sizes may be suitable. The marking tool 4400 may include markingink residing on a surface of a distal end 4404 of the marking tool 4400.In some embodiments, when placing the marking tool 4400 into a patientcavity, a sheath 4406 may be used to cover the ink containing distal end4404, which can then be pulled back or withdrawn by the user to exposethe inked portion of the tool 4400. The length of the exposure 4408and/or distal end 4404 can be determined by the user based on how farthe sheath 4406 is withdrawn. In some embodiments, the ink may only bereleased by the user such that it is on the marking end of theinstrument only after the instrument has been placed in the patient'sbody.

In some embodiments, the distal end 4404 has a relatively long inkedexposure 4408, such as up to between about 6 and 8 inches (between about15.24 and about 20.32 centimeters) in length for marking a large surfaceof the specimen quickly. In some embodiments, the entire distal end 4404may have an exposure 4408. In some embodiments, the exposure 4408 isless than the entirety of the distal end 4404.

Alternatively, in some embodiments, a relatively small exposure 4408 maybe provided, so as to control the placement of ink in a more refined orselective area. Those skilled in the art will understand that the lengthof the exposure 4408 may be adjusted or selected based on a number offactors, including, but not limited to, specimen size, patient size,surgical cavity size, specimen location, and/or other factors. In someembodiments, the marking tool 4400 has an articulating link 4410, toallow articulation of a distal end 4404 relative to a proximal end 4412,to facilitate specimen marking.

In some embodiments, the specialized marking tool 4400 may have a meansfor expanding a diameter of the distal end 4404 once inserted into thepatient, and decreasing the diameter prior to removal from the patient,and in some embodiments back to the original diameter prior to removalfrom the body. In some embodiments, an inflatable balloon 4414 thatcontains the ink on its outer surface may be provided. The user mayinflate the balloon 4414, mark the area of interest on the specimen,deflate the balloon 4414, and then remove the marking tool 4400 from thebody. The balloon 4414 may be contained within a shaft 4402 of themarking tool 4400 and extended from a distal end of the shaft 4402 priorto inflation of the balloon 4414. The ink may be present on theexpanding member prior to insertion into the patient or may reside in asmall pouch within the instrument whereby the user expands the markerand then breaks open or releases the ink so it can then be applied bythe expanded member.

Continuing with FIG. 44, in some embodiments, the distal end may beconfigured to expand within the patient using a fan 4416 or leafspring-like expansion mechanism 4418 holding an ink pad. In someembodiments, a self-expanding material such as a sponge, or a materialthat expands upon exposure to water or a liquid, any memory-retainingmaterial, or similar means may be provided to enable expansion afterinsertion in a patient. That is, an expandable marking end 4414, 4416,4418 may be provided, which may be minimized before removal from thepatient, such as by retracting the expandable marking end 4414, 4416,4418 back into the instrument shaft 4402, or extending the sheath 4406back over the marking end. Those skilled in the art will readilyenvision any number of actuating mechanisms for achieving thisfunctionality.

Turning now to FIG. 45 a bag 4500 with marking features is now discussedin further detail. Since a low temperature cutting approach creates veryclean cuts with minimal damage to the tissue, the segmentation approachmay be used on tissue that will require subsequent pathologic assessmentsuch as in cancer surgeries. As has been described earlier, inks ormarkers may be used to help identify the specimen pieces when in the bagor once removed from the bag. Additional approaches may be used to helpfacilitate pathology.

For example, and as illustrated in FIG. 45, a tissue removal bag 4500may be provided, having different color markers or ink 4502 for eachanticipated tissue segment by housing the ink on a return portion 4504of the bag 4500. The ink 4502 may be heat sensitive ink (or small pouchthat opens with sufficient heat and releases the ink) or similar that isreleased when the electrodes or wires are activated to ensure the ink4502 is placed properly onto the resulting segments. In someembodiments, one or more of the electrodes or wires 4508 may have acolored material 4510 integrated into them that stays behind on thetissue during cutting, for example using a low temperature material thatmelts off the electrodes or wires 4508 onto the tissue.

In some embodiments, the bag 4500 may be manufactured with the ink 4502in one or more relatively small ink pouches 4506 that are attached tothe bag 4500 during manufacturing. Alternatively, the ink pouch(es) 4506may be empty and built into the bag 4500 with the ink injected into thepouches 4506 by the surgeon before or during use through a channelopening on a distal end of the bag. This has the advantage of allowingthe surgeon to select what ink or marker he or she prefers. In someembodiments, one or more ink pouches 4506 may be attached to a returnpad 4504 of the bag 4500. In some embodiments, one or more ink pouches4506 may be attached to a flexible container 4512 of the bag 4500. Insome embodiments, a plurality of ink pouches 4506 are attached to boththe return pad 4504 and the flexible container 4512.

Turning now to FIG. 46, in some embodiments, a segmentation instrumentmay be provided with a distal end 4600. The distal end 4600 may includeink 4602 attached to or coated on one or more expansion petals 4604 thatcause the wire/electrode 4608 to expand, or other segmentationinstrument features. In some embodiments, the distal end 4600 of thesegmentation instrument may have ink 4602 located on one or more distalsurfaces 4606 of a tube and/or one or more petals 4604 intended forcontact with the tissue. Once the segmentation instrument 102 (see e.g.FIG. 1) is pre-tensioned, the specimen is brought into contact with theinked features 4604, 4606.

In some embodiments, the clinician may apply markers after thesegmentation but prior to removal of the segments from the bag. Markingof the samples may be done with a surgical marker, ink 2314 (see e.g.FIG. 45), or a physically attached tag, clip, or RFID tag on the samplesegment ends nearest the exteriorized bag opening. This allows apathologist to reorient the sample segments once they are brought fromthe operating room. These markers may also be integrated into the bag.

As illustrated in FIG. 45, one or more RFID tags 2316 may be attached toor removably attached to the bottom of the bag 2300 on one or more ofthe return portions 2304 (defined by the pattern created by theelectrode(s)/wire(s) prior to cutting). One or more barbs 2318 or anyother means may be provided to cause the RFID tag(s) 2316 to attach tothe tissue segments.

In some embodiments, the surgeon may mark the surface or portion of thespecimen that needs pathologic assessment for margin, prior to or justafter loading the specimen in the bag. This may be done with a marker orink. The specimen can then be segmented, and removed from the patient.The pathologist then knows to find the segments that contain thissurface and to assess for margin or any cancer cells that might be foundon the surface.

Some embodiments include using imaging recognition, including but notlimited to, a digital camera and/or ultrasound to image the specimenprior to segmenting, removing, or during removal of the segments fromthe bag. Digital image processing may then be used to reorient thesegments in order to recreate the specimen using software designed torecognize features on the segments and reorient them in the properlocation relative to each other. A low cost digital camera with digitalimaging software may likewise provide an inexpensive and automated meansfor reorienting segments into their original orientation. This may bedone with or without prior marking of the specimen before imaging.

Some embodiments include reconstructing the excised tissue specimenafter removal, and to use a common imaging means, such as fluoroscopy,on the segmented tissue specimen to determine the location of the areaof interest within the tissue specimen. This may also be used to performadditional diagnostics on the specimen to determine the scope ofpathological assessment required or to guide the remaining surgicalintervention required.

In some embodiments, markers may be used to identify a known tumor orstructure of interest either before surgery or intraoperatively. The bagmay also have markers or fiducials that can be imaged or scanned as partof the loaded bag in order to show the orientation of the specimen (andtumor) relative to the bag. By tracking the specimen segments as theyare segmented and removed the known original location of the tumor, andthus the segments that contain the tumor, may be determined. Thisprovides further information to the pathologist during their evaluation.

In some embodiments, the wires may be used as the fiducials prior to thecutting. To further enhance their location an ultrasound sensitive orradio opaque coating may be applied to a small portion of the wire.Using commonly available image capturing approaches the location of thewires, their projected path of travel, and the location of the tumor canall be determined and analyzed. This information can then guide thepathologist on which segments have particular interest for pathologicassessment. The surgeon or operating room staff may place additionalmarkers on the tissue segments prior to leaving the operating room usingthis image information to identify segments of interest. The images fromthe specimen taken with the wires or bag fiducials that estimate thesegments can also be accessed during pathology to show assembled segmentstructures (i.e. vasculature, tumor, etc.) that can be compared to thesegments themselves.

In some embodiments, a method of cancerous tissue handling is provided.During removal of segmented tissue that is known or suspected of beingcancerous from the segmentation bag, extra care may be desired to ensurethat fluids or tissues do not spill and thereby cause specimen siteseeding. Various methods such as an absorbent pad 4708 may be used tolimit spilling of tissues. The pad 4708 may have a hole in it that isplaced over, under or around the exteriorized bag opening 4710, toabsorb any fluids that may spill (see e.g. FIG. 47).

With reference to FIG. 47, a separate bag 4700 may be provided tocapture tissue segments 4704 as they are exteriorized from the patient.The separate bag 4700 may be twisted about each individual segment 4704as the segment 4704 is removed from the patient and/or a primary bag4702. In some embodiments, the separate bag 4700 may be twisted aboutthe primary bag 4702 as the primary bag 4702 is removed with one or moretissue segments 4704.

In some embodiments, and as illustrated in FIG. 47, an extendable orelongated bag 4700 may be provided to capture the segments 4704 as theyare removed from the patient. For example, an elongated bag 4700 may beoversized in a depth D relative to a maximum width W that is suitablefor a particular tissue to be removed. For example, where a standard bagfor a uterus may have a first width W and a first depth D, the elongatedbag 4700 may have a first width W that is unchanged from the standardbag, and a second depth D that is greater than the first depth D, and insome embodiments, the second depth D may be several times the firstdepth D so as to ensure sufficient material is provided for capturingthe tissue segments 4704.

As illustrated, the elongated bag 4700 may have a flexible containerthat is twistable at one or more twisting regions 4706 so thatindividual segments 4704 may be captured individually. For example asegment 4704 may be captured, the bag 4700 may be twisted to contain thesegment 4704, and the process repeated with another segment 4704 placedin the bag 4700 (note this twisting process applies to the secondary bag4700). Those skilled in the art will understand that even where anelongated or secondary bag 4700, 4700 is provided and enables a user totwist tissue segments 4704 to separate them, the user need not necessaryperform this step, optionally capturing all tissue segments 4704 in asingle cavity. Those skilled in the art will also understand that theuser may optionally seal, tie, clamp, or otherwise fasten the twistedregions 4706 so as to semi-permanently separate the individual segments4704 from one another. In some embodiments, the film 802 previouslydescribed herein may provide a semi-permanent sealing feature betweenthe cavities formed about the segments 4704.

With novel dyes being created for use in identifying cancerous cells insitu, these dyes may be placed in the bag, so once the specimen issegmented, the surgeon can look at the bag to see if any signs of cancerare present in the sample. For example, in a method similar tofluorescence-guided surgery using a cancer cell “homing device” andimaging agent created by a Purdue University researcher, novel imagingagents may be injected prior to surgery, and could be seen in specimenupon removal. Relatedly, a similar imaging agent may be placed in thebag (bag wall, small pouches on bag return, or injected into bag bysurgeon with a syringe or similar instrument prior to or after removingsegments from bag) in a manner substantially as previously describedherein with reference to FIGS. 41 through 46.

Turning now to FIG. 48, a novel method 4800 of tissue segmentation isfurther described herein. The method 4800 includes identifying 4802 atissue type of a specimen to be segmented, selecting 4804 a removal bagfor the specific tissue, inserting 4806 the removal bag into the patientcavity, loading the specimen in the bag, exteriorizing 4808 the bag (andoptionally connecting the bag to a segmentation instrument), andsegmenting 4810 the tissue (and optionally removing the instrument). Themethod 4800 may include removing 4812 the segmented tissue from thepatient and/or the bag.

As previously described, a wire or electrode coating may be provided toenable tissue segmentation at a relatively low power and lowtemperature, with a relatively quick initiation of a tissue segmentationcut.

As illustrated in FIG. 48, in some embodiments, selecting 4804 a bag mayinclude selecting a bag having a wire coating wherein the wire coatingimpedance is matched to the impedance of the tissue being cut. Forexample, lung is a higher impedance tissue than many other tissues foundin the human body. Therefore, selecting 4804 a lung specific bag mayinclude selecting a bag having a relatively higher impedance coatedwire, to optimize energy into the tissue resulting in faster, lowertemperature cuts, than a wire that is used to cut lower impedancetissues such as a uterus or ovarian cyst. The user might select a bagwith specific wire or specific return electrode impedance based on thetissue specimen targeted for segmentation and removal. Those skilled inthe art will understand that various alerts may be provided to indicateto the user which bag has been selected and/or to confirm whether or notthe selected bag does in fact have a coated wire/electrode with animpedance that matches the impedance of the tissue being cut.

Turning now to FIG. 49, a system and method for providing an emergencyrelease, abort or release of the wire connectors of an electrosurgicalinstrument is disclosed herein. In some embodiments, the emergencyrelease 4900 has a plunge cutter 4902 in a slot 4904 in the instrumenthousing 4906, such as between a distal end of a trough (spring assembly)and an introducer tube. That is, the emergency release 4900 may functionsimilarly to a guillotine cutter to sever one or more or allelectrodes/wires 4908 for emergency release, and may be included in thesystem 100 illustrated in FIG. 1.

In some embodiments, an emergency release of the wire connectors fromthe instrument is provided. The emergency release may include a clamp or“brake” associated with the spring(s), which allows the device to bepulled away by a force exceeding the force or strength of the wires,causing them to break.

The emergency release may include pushing the insertion tube against thetissue so that it extends beyond the range of the wires, causing ahigher force on the wires, which ultimately breaks the wires orconnections. The emergency release may include the use of a nitinolspring or clip in the wire crimp barrel that releases the wire crimpfrom the connector barrel. The emergency release may include a member orrelease feature configured to apply a force from behind that re-extendsthe springs to the position prior to tensioning, to allow the user toremove the connectors, retract the distal insertion tube and insert acomponent that can couple to the springs and pull them forward allowingdisconnection by the user. The emergency release may include an aperturethat, when collapsed, constricts around the wires severing theconnections. The emergency release may include a connector system inwhich a magnetic coupling retains the connection, wherein removal of themagnetic field causes the connectors to separate. The emergency releasemay include a release feature integrated into the device, such as alockout collar that is rotatable to extend the spring back to theoriginal position, such as after having moved the spring by rotation ina different direction.

In some embodiments, an emergency release is provided with a tensioningrod designed with a release force just above the maximum range ofintended use, and where the connection point either separates orcollapses when the applied force exceeds a trip point or the maximumrange of intended use. In some embodiments, the segmentation device isconfigured such that the user may apply a higher force away from thepatient, and the tensioning rods are configured to release in response,such as when the higher force reaches a trip threshold or maximum rangeof intended use.

In some embodiments, a lock feature is provided on the tension rod thatopens jaws that hold the connector when force is lost after tensioningis started or with a user initiated control. The lock feature may beused in conjunction with a brake and a relaxation of the force bypushing the device into the patient to release the connectors.

In some embodiments, a cutting feature is provided on the tensioningrod, and configured to cut the wires upon user initiation, such as aknife edge or a pinch point that moves to contact the wires.

In some embodiments, an eject feature on the tension rod is provided andconfigured to eject the connectors at user initiation, lift gates thatsever the wire at the distal end of the tray, electrical excitation,such as a different resonant frequency or energy level, to melt, drive aphase change, soften or release a retainer pin, a pinned connector rodpin pushed out from the back to release.

In some embodiments, and as illustrated in FIG. 50, a release similar toa “kite harness release” in which the tensioning rod has a pin attachedto a loop captured by a collar 5002, the loop 5006 coupled to thetensioning rod end. When the collar 5002 is moved such that it no longercaptures the pin, the pin flips, allowing the tension rod end torelease. The collar 5002 can be moved by an interference designed intothe tube or can be replace by a close contact fit of a tube that holdthe pin from flipping allowing the release. In this manner the releasecan be enabled by using concentric tubes that have slots such that whenaligned with a solid portion of the tube the release cannot occur, asthere is not enough open space to allow the pin to flip, but when thetube is aligned with the slot, the pin will flip and the connectors willrelease the wire(s) 5008 from the spring 5004.

Turning now to FIG. 51 some embodiments, a release similar to a “sailingcable release” which is similar to the ‘kite harness’ described withreference to FIG. 50. By analogy, in sailing, these “under tensionrelease mechanisms” are found in pelican hooks and rope clutches.

In some embodiments, an emergency release including a “jack” engagementis provided, wherein the tensioning rod has a raised portion that alignswith an open portion of a flat spring on the wire connector. The wireconnector is pushed onto the tension rod until the open portion of thewire connector captures the raised tensioning rod. The flat spring onthe wire connector extends distally beyond the tensioning rod and has araised shape that will interfere with features in the lumen of theinstrument if reverse force is applied. This reverse force can bestepped features molded, machined or added to the lumen interior surfaceor can be provided by strips of an interior tube that can only interferewith the spring if rotated to the “release” position, thereby onlyallowing release when the user actively enables that feature.

In some embodiments, an emergency release of the tensioning mechanismand/or other components is provided by way of a detent connection. Forexample, a movable protrusion in a first component and biased towards anextended position may be provided and configured to selectively engage arecess or passage in a second component. The detent connection may beconfigured to selectively release in response to a tripping force or anoverride input.

Turning now to FIG. 52, a spring insulation feature is now described indetail. As illustrated in FIG. 52, a selective insulation region 5202may be provided to prevent the flow of electricity (“drag strip” onlycontacting insulation) and to control when the electrode/wire can beelectrified.

In addition, parallel sections of the spring that are electricallyconductive but not electrically coupled may be incorporated on thespring surface. In some embodiments, this effect is created with theapplication of a thin conductive layer with an insulated backing. By theaddition of these electrical “traces”, separate contact members may beprovided that aligns with these traces to allow different electricalsignals to be coupled along the length of the spring withoutinterference. In some embodiments, the resistance values from theelectrode wire resistors are supplied to a circuit within a fixedportion of the electrosurgical instrument 102, to identify the type ofelectrode, such as in a manner previously described herein.

As illustrated in FIG. 53, in some embodiments, return electrode wiresmay be incorporated in a cutting mesh. The wires 5302 may be activatedas they are retracted, dividing the specimen.

As is illustrated in FIG. 54, some embodiments include a double bag,with an outer bag 5402 and an inner bag having a multiplexed power or RFenergy cutting mesh 5406. To cut the tissue, a mesh of bipolar RFcutting wires may line the retrieval bag. Upon capture, the wires may beactivated (such as in sequence as previously described herein) and cutthe sample into smaller pieces while pulling the mesh into the shaft. Bysealing the bag against the shaft, inflating the bag, such as by using aballoon 5404 in or coupled to the outer or inner bag 5402, 5406, mayalso assist in pushing the sample or pieces of the sample into theshaft. The resulting segmented pieces may be elongated pieces.

As is illustrated in FIG. 55, some embodiments include a collapsiblebasket 5502, such as a cutting mesh or basket 5502 of electrodes 5504oriented perpendicular to the open specimen bag, allowing tissue to becaptured therein. The bag may then be closed about the shaft andreoriented to be parallel to the shaft axis and wire mesh. The wires maythen be activated as they are pulled into the shaft to cut the specimeninto smaller pieces. The resulting segmented tissue pieces may be pieshaped.

As is illustrated in FIG. 56, some embodiments include a rotatingbipolar power such as a radio frequency energy cutting mechanism and astationary specimen, held by the bag. The cutting mechanism 5602 may beconfigured to advance or move distally or proximally as it rotates. Theresulting segmented tissue 5604 may be removed from the specimen duringthe procedure. The return electrode 5606 may be a part of the bag.

As is illustrated in FIG. 57, in some embodiments, a rotating cuttingmechanism 5702 may include rotating wires. The rotating wires may havesharp corners to maximize current density and/or to bend to expand thecutting structure.

As is illustrated in FIG. 58, in some embodiments, a single bipolarelectrode wire may be provided to divide the disuse. The wire 5802 maybe advanced and retracted while rotating to different orientations. Theresulting tissue segments may be substantially cylindrically shaped.

As is illustrated in FIG. 59, in some embodiments, active electrode(s)5902 and return electrode may be wrapped around the specimen or arrangedsuch that the wires can be constricted around the specimen that iscaptured in the retrieval bag. The wires may then be retracted andactivated simultaneously to divide the sample. The resulting tissuesegments may be substantially shaped like segments of rotini pasta.

As is illustrated in FIG. 60, in some embodiments, a cutting/graspingloop in the retrieval bag 1616 may be provided. The cutting loop may bean electrode that is extended down the retrieval bag shaft. The wires6002 may travel from the exterior of the specimen and “scoop” and cutthe specimen into smaller, more manageable pieces. An articulator may beprovided. The electrode wire loop 6002 may be collapsed or collapsibleon each segmented piece 6004 to pull it out of the patient cavity. Thetissue segments 6004 may look like orange slices.

As is illustrated in FIG. 61, some embodiments provide for a stationarycutting mechanism 6102 with moving tissue 6104. For example, thespecimen 6104 may be pulled into a bipolar RF electrode wire 6102. Thespecimen may be captured in the retrieval bag portion of the device. Thebag may then be pulled into the device shaft, passing through anactivated wire electrode along the way. To encapsulate the specimenbeing cut, another bag 6106 or electrode mesh may be exterior of thespecimen. The mesh may also serve as a return electrode. The bag/cuttermay be manually rotated to obtain multiple cuts in the tissue.

As is illustrated in FIG. 62, a push-pull electrode grid with anexpandable funnel may be provided in some embodiments. The specimen maybe drawn into the device shaft through a plurality of electrodes. Thedistal end of the shaft may expand into a funnel 6202 to gather thespecimen into the shaft as the retrieval bag is pulled in. Theshaft/cutter may be manually rotated to obtain multiple cuts.

As is illustrated in FIG. 63, some embodiments provide for pulling aspecimen into a multistage rigid electrode or RF cutting mechanism. Aseries of bipolar electrode wires clocked at different angles to cutthrough tissue as the tissue is drawn into the device shaft. No manualrotation is required. The electrode wires may be inside the funnel, suchas at a first stage 6302 and a second stage 6304.

As is illustrated in FIG. 64, some embodiments provide a stationarycutting wire with a grasper/manipulator as a return electrode. In someembodiments, one or more stationary electrode wires 6402, with agrasper, which may also be the return electrode, is used to pull thespecimen into the electrode wires. The segmented tissue may be removedthrough the shaft or incision. The funnel 6202 illustrated in FIG. 62may be provided here as well.

As illustrated in FIG. 65, some embodiments may provide for a rotatingedge peeling/cutting action. For example, rather than only pushing oronly pulling the specimen through the wire, some embodiments provide a“skewer” 6502 to rotate the specimen through one or more bipolarelectrode cutting wires or wire loops. This creates a spiral cut as thespecimen is drawn into the shaft, which elongates the segmented tissue.

As illustrated in FIG. 66, a spiral cutting electrode may be provided insome embodiments. In some embodiments, a rotating skewer or a rotatingbag may impart rotation on the enclosed specimen. One or more bipolarelectrode cutting wires may then be used to skive/scallop the tissue asit is pulled through/against the wire. The skewer and/or the bag mayinclude the return electrode.

As illustrated in FIG. 67, an electrode construction 6700 may includethread 6704 woven with metal filars 6702. The return electrode 6700 maybe incorporated into the fabric making up the specimen bag. For example,wires 6702 woven directly into the thread 6704 used to make the bag mayprovide one embodiment of a return electrode 6700.

As illustrated in FIG. 68, a bipolar/bifilar wire pair arrangement 6800may provide an electrode construction 6800. In some embodiments, aseries of bifilar wire pairs may be provided to enable bipolar RF energyfor creating cuts. Each wire pair 6800 may include an active electrode6802 and a return electrode 6804. The wires 6802, 6804 may be exposedthrough the insulation 6806 on opposing sides of the structure by way ofone or more windows or recesses 6808 in the insulation 6806.

As illustrated in FIG. 69, although most wire electrodes illustratedherein are shown as substantially rounded, those skilled in the art willrecognize that wire electrodes 6900 having other wire electrode shapesare envisioned, such as a square wire electrode 6900. A square wireelectrode 6900 may maximize current density at the corners. This mayreduce the power required to initiate cutting using bipolar RF energy.The wire 6902 may have a coating 6904. The corner(s) 6906 of the wireelectrode 6900 may provide an area to concentrate the current density,thereby making cutting or cut initiation more efficient.

As illustrated in FIG. 70, some embodiments of a bag construction 7000may include a bag 7002 that incorporates both the return electrode 7004and the active electrode 7006 for applying power, such as bipolar RFenergy. A converter may manufacture the structure 7010 prior to weldinga flat pattern into a bag shape.

As illustrated in FIG. 71, some embodiments provide for a bipolarelectrode 7102 and a return electrode woven into the bag. In someembodiments, fine wires 7104 may provide the return electrode. The finewires 7104 may be woven into a polymeric fabric 7106 that forms theretrieval bag.

As illustrated in FIG. 72, some embodiments provide for a bagconstruction 7200 having active and return electrodes. In someembodiments, active electrode wires may be incorporated into thespecimen bag by providing a multilayer construction. The outer layer7202 may include a nylon or elastomer, the next layer 7204 may include afoil return, the next layer 7206 may include an insulating layer, thenext layer 7208 may include the active electrode wire(s), and the nextor innermost layer 7210 may include a perforated bag material.

As illustrated in FIG. 73, some embodiments include a dual bagconstruction 7300 for pre-tensioning the specimen. The dual bagconstruction 7300 may include an interior bag 7302, which may constrictthe specimen by collapsing against the device, while the outer bag 7304may contain or enclose the wire(s)/electrode(s) (not illustrated) usedfor cutting the specimen. The return electrode (not illustrated) mayalso be housed in the outer bag 7304.

As illustrated in FIG. 74, some embodiments provide a dual bagconstruction with return electrodes (not illustrated) in the outermostbag 7402. A dual layer bag construction 7400 may be used such that theouter bag 7402 constricts the specimen and contains the returnelectrode. The inner bag 7404 may contain the active electrode(s) (notillustrated) for cutting.

As illustrated in FIG. 75, some embodiments provide an in-cord signalcontroller (multiplexing). To address the potential use of a variety ofgenerators for the power (such as RF energy) driving the cutting, acontroller 108, 708, 7502 may be provided in series with the devicecable. The controller 108, 708, 7502 may be used in conjunction with aproject requiring multiplexing of the signal.

As illustrated in FIG. 76, a retrieval bag 7602 may be provided with anover tube 7604 for cutting and exteriorizing tissue. In someembodiments, support arms 7606 and drawstrings 7608 positioned betweenthe over tube 7604 and the main device shaft (not illustrated) mayassist in reorienting the retrieval bag 7602. In some embodiments,providing two or more drawstrings 7608 may provide improved control ofthe bag closure and increase the tendency of the bag to 7602 close overthe device shaft (not illustrated).

As illustrated in FIG. 77, in some embodiments, a method of using thespecimen retrieval bag 7602 is provided. One method includes capturingthe specimen in the bag 7602, and then dividing the tissue into smallerpieces for removal. The bag 7602 may be initially open perpendicular tothe shaft (not illustrated) as illustrated in FIG. 76, and then rotatedover the shaft/through the incision, as illustrated in FIG. 73, forapplying a cutting to the specimen therein, using one or more electrodes7610. External drawstrings 7612 may assist in positioning the bag 7602.

As illustrated in FIG. 78, some embodiments provide guides for wireloops. For example, a shaft tip 7802 or distal portion of a shaft mayinclude a guide 7804 for each wire electrode 7806.

The guides 7804 may bias the wires 7806 away from each other to preventthem from touching, thereby maintaining the cutting path of the wires7806.

As illustrated in FIG. 79, a cam tube 7902 for activating bipolar powerand tensioning of each wire loop may be provided in some embodiments.The cam tube 7902 may organize the sequencing of each cutting wire. Thetube may have slots 7904 to only allow one loop or loop pair to activateat a given time. Each loop/loop pair may be pulled manually. Rotatingthe cam tube may control which wire is available for power or RF energyactivation as well.

As illustrated in FIG. 80, a wire loop with opposing springs 8002 tocontrol the wire tension over time may be provided. In some embodiments,a pair of springs or other components may be used to automate the wireforces during cutting, thereby creating a variable spring force on thewire 8004 over the pull through the tissue. Applicant has determinedthat slowing the rate of pull near the end of the cut reduces sparkingor flashing of the electrodes.

As illustrated in FIG. 81, a handle or shaft structure for individualwire loops may be provided. In some embodiments, a rotation ring 8102 ina shaft construction 8100 may be used to release wire columns that areactively tensioned by extension springs. A user may rotate the ring torelease one rod and activate the power or RF energy. In someembodiments, each cut requires about 20 to 25 centimeters (or about 8 to10 inches) of travel may be provided.

Embodiments disclosed herein may be used in polypectomy, dissector, orother applications where wire cutting with coagulation or hemostasis isdesired.

As illustrated in FIG. 82, a manual wire retraction may be providedinstead.

As illustrated in FIG. 83, torsion springs 8302 for achieving wiretension during a cut may be provided. The torsion springs 8302 may beconstant force springs, and may provide for the retraction of cuttingwires/electrodes 8304. The torsion springs may coil the wire or otherstructure that pulls the wire into the device shaft. The torsion spring8302 may operate sequentially.

As illustrated in FIG. 84, some embodiments provide for electrode wireactivation using a cam and lobe mechanism 8400. A rotating cam may lifteach radially spaced wire/electrode out to another electrical contact,to select wires/electrodes for power or RF energy. The cam may berotated to release one wire/electrode and activate another.

As illustrated in FIG. 85, some embodiments provide for a wire/electrodelength lock mechanism 8500 or method. In some embodiments, a cam lockslide is provided, and may be advanced onto the wire/electrode until acertain force is achieved. The cam may then lock the wire/electrode inplace as the wire/electrode relaxes slightly. The cam lock provides fora method of pre-tensioning the wire/electrode against the specimenbefore initiating power and/or cutting tension.

During low temperature, rapid wire cutting applications, the delivery ofenergy where some level of hemostasis is desirable may be altered toprovide both hemostasis as well as rapid cutting.

One means to increase hemostasis is to alter how energy is appliedinitially during a wire cut. A voltage limited power, with a low voltageand higher current capability, may be delivered initially to thetensioned wire cutter so as to delay the cut initiation and allowingcoagulation of tissue prior to cutting. At a predetermined time or untila predetermined parameter threshold is met, the energy delivery couldthen be altered such that the wire cutting is initiated throughincreased voltage. Another means to accomplish this would be toinitially apply a non-sinusoidal waveform to enhance the coagulationeffects and to transition to a sinusoidal waveform to enhance cutting.This can be a single event or can be continuously adjusted as the cutadvances. This may also be adjusted by modulating between a puresinusoidal waveform and a higher crest factor waveform based on feedbackfrom electrical or rate of travel data to improve control and thecutting performance. This modulation can be pulse width modulation,changing distortion characteristics of the waveform, elimination orchanges in amplitude of cycles or partial cycles of the output, changingdampening characteristics by adding or subtracting loads on the RFoutput stage, or other means.

Parameters that may be of interest to monitor include electricalparameters such as impedance or phase change or mechanical parameterssuch as tissue shrinkage or compliance. During the initial hemostasisstep a higher force may be applied to the wire during coagulation thanis required for the cutting alone with pressures as high as 100-200 psi.The force may then be lowered or maintained to complete the cutting.Coagulation or hemostasis times may vary, but times are expected to bebetween 0.25-10 seconds. Wires may or may not have high impedancecoatings or alternatively a nonstick coating depending on theapplication.

Turning now to FIG. 86, it illustrates an instrument 8610 suitable formaintaining pneumoperitoneum during the loading of the bag 8611. Theintroducer 8610 may have a sealer 8612 on the shaft 8614 that provides aseal when pushed against the incision site. This sealer 8612 may be onthe inside or outside of the patient. The sealer 8612 may include aninflatable or non-inflatable feature. The user may be able to move orslide the sealer 8612 along the length of the shaft 8614 to positionsealer 8612 at or near the incision and/or to move the sealer 8612 awayfrom the incision at a suitable time. In some embodiments, the sealer8612 includes a cup-shaped feature that surrounds or encloses theintroducer shaft and is flexible at the introducer shaft to enablemovement of the introducer with minimal movement of the cup-shapedfeature. In some embodiments, an opening that interfaces with theinstrument 200 is compliant such that the sealer 8612 can be removedafter use and placed on another instrument (such as a grasper) intendedto help with the loading and exteriorizing of the bag 8611.

In some embodiments, it may be desirable to reliably close a removalbag, such as for lap to vaginal removal. For example, in someembodiments, a bag sealer tool may be provided to seal the bag openingby melting the bag together. Here, material having a relatively lowermelting temperature may be provided at the opening end of the bag formore reliable, easier sealing. In some embodiments, a large clip or tiemay be provided to enable a reliable closure. Here, the user may applythe clip or tie over or about a malleable material (such as a wax and/oradhesive) area or strip that is permanently attached to the bag openingto provide a fluid impermeable barrier between the contents of the bagand the exterior. The malleable material may be provided on an interioror exterior wall of the bag. Providing the malleable material on theexterior of the bag may reduce the potential or accidentalpre-engagement, with engagement made possible after, for example, theuser flips an end of the bag in. In the alternative, a removable stripon the malleable material may be provided, so as to preventpre-engagement.

Turning now to FIGS. 87a-87c , means for aiding in the removal ofsegments with the bag are now described in detail. After segmenting thetissue into segments 8722, it may be desirable to remove the bagsimultaneously with the specimen segments 8722, particularly insituations where cancer is suspected or known. In this situation, a bag8724 configured to apply a compressive force on the tissue to be excisedmay be provided.

For example, and as illustrated in FIG. 87b , the bag 8724 may include asegment constrictor 8726 that compresses and/or reorients the segments8722 while simultaneously applying a force to remove the bag 8724.Specifically, the segment constrictor 8726 may be configured such that,as a user pulls proximally on the segment constrictor 8726, the segments8722 are compressed simultaneously or substantially simultaneously asthe bag 8724 is pulled out of the patient (see e.g. FIG. 87c ). In someembodiments, the segment constrictor 8726 is integrated on the interiorof the bag 8724 to facilitate the reorientation of the tissue segments8722 through direct contact. The segment constrictor 8726 may be astring or a strap-like feature. In some embodiments, the segmentconstrictor 8726 may have a memory-retaining material and/or beresilient so as to assist in expanding the bag 8724 to accept thetissue. In some embodiments, the surface of the segment constrictor 8726is roughened or has protrusions that either increase the coefficient offriction between the segment constrictor 8726 and the segments 8722, oreffectively “grab” the segments 8722 as the user or instrument pullsproximally.

In some embodiments, and as illustrated in FIG. 87c , the segmentconstrictor 8722 is configured to apply a constricting force that is atan angle relative to the direction of a cut or a pull force F. Byapplying a constricting/pulling force at an angle a of between 15-90°relative to the direction of the cut, wire retraction, or pulling force,the segments 8722 may be both compressed and repositioned to allow forremoval through the incision. If more compression is desired closer to a90° angle may be desired; in some embodiments, the angle a is between45° and 89°; in others, the angle a is between 60° and 85°; in others,the angle a is between 70° and 80°. If more movement or reorientation ofthe segments is desired, the angle may be closer to 15°. In someembodiments, the angle a is between 15° and 45°; in some, the angle a isbetween 15° and 35°; in others, the angle a is between 15° and 20°.

As illustrated in FIG. 88, in some cases, a robotic or otherelectromechanical means may be utilized for a surgery. In such cases, itmay be desired to utilize the same means to remove the segments from thebag. FIG. 88 illustrates an exemplary approach to enabling roboticassisted removal. As illustrated, a system 8830 having a tissue removalbag 8831, a robotic grasper 8832, a guide means 8834, and a bag-machineinterface 8836 is provided in some embodiments.

The robotic grasper 8832 may include a camera on an arm 8835 to allow asurgeon to view the robotic grasper 8832 going in and out of a patient'sbody or incision. The guide means 8834 provides the ability to guide therobotic grasper 8832 in and out of the incision or a trocar including aguide between the trocar or incision site. In some embodiments therobotic grasper 8832 is configured to travel between the incision siteand another location (such as a specimen or pathology container, or atray to receive tissue).

The bag-machine interface 8836 may be provided on or proximal to the bagopening, and is configured to interface with a robotic arm 8838 andallow the arm 8838 to provide tension on the bag 8831 during removal ofthe tissue segments 8822 such that the segments are easily identifiedand grasped

Some embodiments disclosed herein may be used for removing lung tissue.For example, a surgical method provided herein includes (not necessarilyin this order): (1) Mark or identify margin or area of interest forpathology (optional). (2) Insert specimen bag into thoracic cavity forspecimen capture. (3) Load specimen in bag. (4) Exteriorize bag opening.(5) Connect wire connectors to instrument. (6) Insert distal end ofinstrument into thoracic cavity. (7) Pretension wires prior to cutting.(8) Segment tissue using either mechanical or mechanical/electricalcutting. (9) Remove instrument. (10) Apply external compression force ontissue segments at an angle between 15-90° to the direction of cuttingor wire retraction pull force in order to decrease bag diameter and/orre-orient tissue segments. (11) Remove bag with contained specimen(s).

A tissue removal method disclosed herein includes (not necessarily inthis order): (1) Mark or identify margin or area of interest on specimenfor pathology (optional). (2) Insert specimen bag into thoracic cavityfor specimen capture. (3) Load specimen in bag. (4) Exteriorize bagopening. (5) Connect wire connectors to instrument. (6) Insert distalend of instrument into thoracic cavity. (7) Pretension wires prior tocutting. (8) Segment tissue using either mechanical ormechanical/electrical cutting. (9) Remove instrument. (10) Removespecimen segments. (11) Remove bag.

The temporary holding of wires to the bag may be performed in severalmanners. Bags may include multiple layers, or single layers withadditional features attached to temporarily hold the wires in place. Thebags may include several film pieces welded or adhered together, or theymay be molded by reshaping a film, or blown in a mold similar to aballoon. Regardless of the approach, the means by which the wires areheld in place must be releasable and release in order to complete thesegmentation of the tissue.

Another important feature of using wires to segment a specimen, eitherwith or without radiofrequency energy, is to ensure that the wires areheld to the side wall of the bag, as illustrated. By keeping the wire(s)temporarily attached to the side wall of the bag, the specimen may beloaded without inadvertently shifting the wire(s) or catching on thewires so the specimen can't be fully loaded. For this purpose, the wiresmay be held in place using loops, perforations or similar bag featuresthat release with tension applied to the wires. In addition, the holdingfeatures may release in response to an application of energy to thewires that melt or soften the holding features. An additional approachis to have a mechanical pull or feature that the user can pull thatreleases the wires from the holding features. The mechanical pull orfeature may be separate strings attached to the holding features thatthe user can access near the opening of the bag when exteriorized.Inflatable features within the bag itself may also be used to rupturethe holding features.

One potential risk of temporarily attaching wires to the bag is that thebag ruptures during detachment of the wires. The use of multiple baglayers will help to ensure that the bag remains intact upon release ofthe holding features. The holding features are attached to the mostinner layer of the bag, with one or more additional layers on theoutside of the bag to ensure the bag remains intact and impermeable tofluids.

Additional features may be added that provide feedback to the userregarding bag integrity. The bag may be inflated or have inflatablechannels. With inflation, the measured inflation pressure that the bagor inflatable channels holds is an indication of any possible holes inthe bag. Use of a pressure valve with a sensor can be used to detect anydrop in pressure. The pressure valve and/or means to inflate the bag orinflatable channels may be integrated into the bag or alternatively beintegrated into the segmentation instrument itself. Other potentialapproaches include use of a camera to allow the user to view the outsideof the bag during the procedure, use of a color changing indicatorwithin the outer two layers of a three layer bag that changes color uponcontact with bodily fluids, or use of clear outer bag layers or filmswhere the user can visually determine if any fluids have penetratedbetween the two layers. Another method could be to have a conductivedeposition on the inside of the outer bag layer and a center layer thatis separated to the outer layer by the inflation. The capacitancebetween the two conductive layers can be monitored such that a drop inpressure will change the capacitance reading, similar to a capacitivetouchscreen press. The capacitance can be measured at regular intervals,on command or continuously or a threshold can be predetermined such thatif the pressure is lost, the system can identify the condition and issuean alert. The two conductive layers can also be used in a similar manneras a resistive touchscreen in that the change in resistance between thetwo layers can be used to indicate a loss of pressure condition. Lastlythe outer two layers of the bag may contain a sterile fluid by which theuser can be confident of bag integrity if the fluid level has not fallenduring the course of the procedure.

If the user visually determines a void in the bag, an adhesive patch maybe applied in situ to reduce the risk of bodily fluid or tissue lossfrom the bag contents. The user may also decide to wash (rinse andsuction) the patient's body cavity.

Although this document primarily addresses electrosurgical systems, itshould be understood that tissue segmentation and removal may, in someembodiments, but achieved using a segmentation device that does not havean electrosurgical component. Specifically, a surgical device having oneor more wires that segment tissue mechanically, such as by force,motion, and/or vibration may be provided. Many of the examples disclosedherein also apply to such a mechanical surgical device. For example, asurgical device may utilize wire tensioning methods disclosed hereinwithout the electrical aspects, and with or without a controllerconfigured to control the pull forces or speed of cut. Similarly, therobotic system may also provide a cutting function that is notelectrosurgical in nature. As in the case of the electrosurgicalsegmentation procedure, the removal bag may provide means for keepingthe cutting wires in place (and from entangling with each other) while atissue segment is placed in the removal bag, and, similarly, the wiresmay be configured to detach from the removal bag at a desired set forceor time. The use of mechanical only cutting may be advantageous inapplications where the tissues are not calcified, have less variabilityof mechanical properties, or are generally more friable, and thereforedo not require extremely high forces to cut reliably through thetissues. To address this case, the tissue removal device or wire cuttingdevice may be configured without the elements that are required forelectrosurgical cutting; for example the return electrode or connectionsto the controller or an electrosurgical generator may be omitted. Thoseskilled in the art will understand that a removal device without theelectrosurgical cutting elements requires a smaller number of usercompleted instrument connections. In turn, this may lower the productioncosts of the product. In some embodiments, a removal device that doesnot have an electrosurgical cutting feature allows for cutting tissue ata lower temperature, and may be a safer alternative for weaker patients.Those skilled in the art will understand that the mechanical pullforce(s) in a removal device without electrosurgical cutting will besignificantly greater than one with an electrosurgical cutting feature.

As was previously mentioned in U.S. patent application Ser. No.14/805,358, there may be some benefits to a bipolar application of RFenergy. FIG. 89 illustrates an embodiment of a bipolar wire assembly8950. The wire is created with two electrically conductive outer regions8951 and 8952 that are separated by an insulation member 8953. The twoconductive regions 8951 and 8952 are not electrically coupled, and theseparation of the insulation member 8953 is such that the voltageapplied to perform the tissue segmentation does not arc across theinsulation member. The RF voltage may be applied between conductiveregions 8951, 8952 with one acting as an active electrode and the otheractive as a return electrode. In some the optimal embodiments, theconductive regions 8951, 8952 and the insulation member 8953 are bondedor formed such that they are mechanically coupled and they are twisted554 over the length of the wire assembly. This twisting ensures contactof both conductive regions 8951, 8952 with the tissue at some pointacross the tissue specimen. The initiation of the cut will happen atsome point across the length of the wire assembly and as the wireadvances into the tissue during the cut, contact will be made over theentire length of the wire. Configuring the device as described here mayincreases the probability that both conductive regions will remain incontact with the tissue through the completion of the cut.

FIG. 90 illustrates a bipolar wire assembly 9060 having two parallelwires 9061, 9062 separated by an insulation member 9063 mechanicallybonded or formed together to create a mechanical coupling. Thisconfiguration may be left in parallel or twisted as described withrespect to FIG. 89.

As previously described herein, rupture of the bag 161 is a potentialfailure that should be monitored, prevented, and/or mitigated, whetherwith a tissue segmentation device or simply with a removal device thatdoes not segment tissue.

With reference now to FIG. 91, a removal bag system 9100 may be providedthat includes an outer bag layer 9102, an inner bag layer 9104, and aspace 9106 therebetween. The layers 9102, 9104 may be coupled to orfused to one another using any means known in the art, such as at ajoint 9108. Either vacuum or pressure between the bag layers 9102, 9104may be used as part of a breach detection or mitigation strategy.

In some embodiments, pressure in the space 9106 between the layers 9102,9104 may be used to inflate the outer bag layer 9102. If a breach occursin the outer bag layer 9102, the loss of pressure can be detectedvisually by looking for a decrease in inflated bag size or pressure.

In some embodiments, a vacuum may be applied to the space 9106 betweenbag layers 9102, 9104. The vacuum may serve two purposes: first, avacuum may provide a visual indication of a breach if the outer baglayer 9104 no longer appears to be pulled towards the inner layer 9104.Second, if a breach occurs in the outer bag layer 9104, the vacuum willdraw air into the space between the bag layers 9102, 9104 therebyminimizing the potential for other materials or fluids to escape thehole (in particular if the hole is small). That is, a vacuum in thespace 9106 between layers 9102, 9104 may tend to bias an inward flow offluid, whereas a pressure in the space 9106 would tend to, in the eventof a breach, release fluid out and potentially into the patient.

In some embodiments, and as is illustrated in FIG. 92, the removaldevice 102 may include a CO2 and/or N2O sensor, positioned, for examplein the introducer tube, to detect the presence of the gas being used forinsufflation. That is, for example, if the bag 161 is introduced intothe patient cavity in a vacuum state or with atmospheric air therein,the gas used for insufflation, such as carbon dioxide or nitrous oxide,will tend to enter the interior space 9204 of the bag 161, and thesensor 9202 may be provided and configured to detect the change in thegas signature and/or to detect that the gas in the interior space 9204has insufflation gas therein. Those skilled in the art will recognizethat the sensor 9202 does not necessarily need to be inside the removaldevice 102 but merely needs to be exposed to the interior space 9204 forsampling, using any suitable means known or as-yet developed in the art.

Turning now to FIG. 93, in some embodiments having multiple bag layers,a tube (not illustrated), lumen, or channel 9308 may be provided toexpose the sensor 9202 to the intermediate space 9306 between the outerand inner layer bag layers 9302, 9304. The sensor 9202 may be positionedremotely from the bag assembly 9300, and coupled to the channel 9308such that the sensor 9202 may sample the contents of the air in thisintermediate space 9306.

In some embodiments, a slight vacuum may be applied to the space 9106,9306 between layers 9102, 9104, 9302, 9306 or the bag interior 9204,such that the content of gas being detected at the sensor 9202 isincreased, thereby providing a more accurate indication of a leak. Thisslight vacuum may be created using a pump (not illustrated), evacuatedair cylinder or other means to apply a negative pressure, including, butnot limited to, an air flow control valve coupled with the sensor 9202to draw the contents of the space 9106, 9306, 9204 toward the sensor9202 and ensure that the negative pressure can be maintained throughoutthe procedure.

As illustrated in FIG. 94, in some embodiments, one or more channels9410, 9412 may be provided and coupled to the intermediate space 9406between the outer and inner bag layers 9402, 9404. A first channel 9410may be coupled to a vacuum pump 9408, and used as previously describedto provide a negative pressure to sample the contents of theintermediate space 9406. A second channel 9412 may be provided toresupply the space 9406 with the air that has been pulled out of thespace 9406 or other air. In this manner, a circulation of air is createdthat may be continuously monitored, such as at the sensor 9202 using oneof the channels 9410, 9412 previously described or another channel 9416.

This monitoring may establish a baseline and/or provide a more accurateindication of the starting level of CO2 and/or N2O. The sensor 9202 may,in some embodiments, monitor for differential or changing levels of CO2and/or N2O as previously mentioned herein. In some embodiments, the bagsystem 9500, as illustrated in FIG. 95, may include a HEPA, carbon,and/or other filter to condition or maintain the air quality of thespace 9204 being monitored. For example, if the channels 9410, 9412 arecoupled to the interior of the bag 161, any steam, smoke or othereffects that are created from the cutting process may be reducedsignificantly within the bag area 9204.

The sensor 9202 may be used independently and/or may include a visual oraudible indication when CO2 and/or N2O is detected. The sensor 9202 mayalso be electrically coupled to a processing unit such as the controller108, 808 that can create an audible or visual indication to the userwhen CO2 and/or N2O is detected. The sensor 9202 may also beelectrically coupled to the instrument 102 or may be coupled to aseparate device that is dedicated to detecting the presence of a leak inthe bag 161, 9100, 9300.

An alert provided to the user upon indication of CO2 and/or N2O mayallow the surgical team to perform surgical intervention at the earliestpossible opportunity to best manage the outcomes for the patient.

In some embodiments, and as illustrated in FIG. 95, one or more sensors9518, 9520 provided in-line with the pumps 9408, 9414 may be configuredto monitor the quality of a fluid beint introduced into and exiting fromthe bag 161, or space between two bags 9302, 9304. That is, the system9300, 9400, 9500 may be configured to detect a change in gas that is inthe interior space 9204 or space 9106, 9306, 9406, 9506. A method ofleak detection may include comparing one or more fluid quality valuesdetected at a first point in time with one or more fluid quality valuesdetected at a second point in time.

The system 100 may use this information to alert the user of a leak asit occurs to allow the surgical team to perform surgical intervention.

With continued reference to FIGS. 91, 93, 94, and 95, in someembodiments, a high pressure air or fluid may be applied to the space9106, 9306, 9406, and an acoustic or ultrasonic wave in the range of20-50 kHz may be applied to the pressurized structure. An acoustictransducer (not illustrated) may be provided to monitor the acousticemissions of the structure and detect changes in the emissions thatwould be indicative of a leak or change in the structure. The acousticemissions detection utilize one or more of the following techniques:ringdown counts, energy analysis, amplitude analysis, frequencyanalysis, pattern recognition, and/or spectral analysis to detect thechange in acoustic emissions, or any other means known to those skilledin the art.

In some embodiments, a post-surgical procedure leak detection method isprovided. For example, fluid pressure may be applied from a pump,cylinder, or other means to the space 9106, 9204, 9306, 9406 between theouter and inner bag layers or to the inside of the bag 161 with the bag161, 9100, 9300, 9400 sealed around the air pressure device. A pressuredetector may be used to measure the resulting air pressure, and/or decaycharacteristic. A visual indication to determine if a leak has occurredmay also be provided.

The detection system may include a pressure detector, a pressure-controlvalve to limit the applied pressure and a vent mechanism. Forembodiments that use the intermediate space, the lumen that providesaccess to the space can have a fitting that allows easy attachment ofthe leak detection system by the user. For embodiments that use the bagopening, an interface that fits into the bag opening and allows the userto constrict the opening onto the interface creating a seal. The bag mayalso have features that aide in creating a seal against the interface toimprove the ability to perform the test.

The post-surgical leak detection method may allow the surgical team toperform a surgical intervention, if necessary, prior to completing thesurgery.

In some embodiments, a leak detection method may include a fluid wash(such as sterile saline) between the bag layers after usage. Thecontents of the fluids may then be evaluated for biologic materials suchas blood.

In some embodiments, a post-surgical leak detection method may includeinflating a bag and placing under a liquid such as water to look forbubbles.

In some embodiments, after completion of the segmentation procedure, thespecimen bag may be evaluated for leaks. For example, the operating roomair supply may be used to fill the interior of the used specimen bag byhand grasping/sealing the bag opening around the air supply whileinflating. Once the specimen bag is inflated, the opening may be twistedaround itself to seal in the pressurized air. This inflated specimen bagmay be (partially) submerged in a bath of water (i.e. a small cavity ofthe tray in which the specimen bag was shipped) to visually inspect forair bubbles escaping any breaches in the specimen bag. A surfactant maybe added to the bag surface or water bath to modify the surface tensionof the water and enhance the visible bubbling of the water.

Some embodiments of leak detection may include filling the intermediatespace between bag layers or the interior of the specimen bag with aliquid, such as water or saline, and adding pressurized air to apredetermined pressure, thereby accelerating any leaks through anybreech in the bag or bag layers.

In some embodiments, the bag surface may be visually inspected and/ormay be dried with a towel or air, and migration of the liquid across thebag layer boundary may be visually inspected.

In some embodiments, a coloring agent or dye may be provided in thefluid introduced into the space, to enhance the ability to visuallyidentify the migration across the bag or bag layer boundary.

In some embodiments, an outer bag layer 9102 may be made of a firsttranslucent color and an inner bag layer 9104 may be made of a secondcolor, and a space 9106 therebetween may be pressurized. A method ofdetermining a leak may include visually determining a perceived changein color at one or more points of contact between the bag layers 9102,9104. Visually determining may include using an endoscopic camera orviewing the outer layer 9104 during or after the surgical procedure.

For example, if the inner bag layer has a blue tint applied, and theoutside layer has a yellow tint applied, the area of contact will resultin a green tinted shape due to increase in optical coupling of the twocolored layers.

In some embodiments, as the surgical procedure proceeds, a change is thesize of the combined color area, particularly an increase, may indicatea change in the area of contact between the two layers. If a fixedvolume of air is captured between the two layers in this intermediatespace or if a slight pressure is applied prior to use, the increase ofsize of this color combined region can identify a leak of one of the baglayers.

Those skilled in the art will recognize that the procedure describedabove may also be suitable where a space 9106 between the layers isunder vacuum. For example, if the layers 9102, 9104 pull away from eachother, a leak is also indicated.

In some embodiments, a method of leak detection may include providing amoisture detection layer, and/or monitoring an electrical patternindicative of conductive fluid or change in impedance due to fluids

As illustrated in FIG. 96, which illustrates a side section view and apartial top view, a method of detecting a leak, such as of the innerlayer may include providing an electrically conductive mechanism 9606 inthe intermediate space between the inner bag layer 9604 and outer baglayer 9602. The mechanism 9606 may be a conductive film or mesh, and/ormay be a coating or layer deposited or printed onto the outer surface inthe inner bag layer 9604 and/or the inner surface of the outer bag layer9602.

In some embodiments, a first electrode 9608 and a second electrode 9610may be positioned between the layers 9602, 9604 with or without the restof the conductive mechanism 9606 or mesh.

The conductive mechanism 9606 may be in a pattern having a fixed spacingbetween two separate electrodes 9608, 9610. The two electrodes 9608,9610 may be a single pair of electrodes that cover some or most of theinternal surface of the bag layers or may be pairs placed at multiplelocations that are electrically connected in parallel. The electrodesmay be electrically coupled to a signal, preferably an AC waveformsimilar to the dual electrode monitoring interrogation waveform appliedby electrosurgical generators to monitor return electrode contactquality. The signal may be generated from an electrical circuit locatedin the segmentation instrument 102, the monitoring unit or controller108, or a separate remote location. The characteristics of the voltagemeasured across the electrodes and the current measured between theelectrodes can provide the impedance across the electrodes. If theintermediate space is dry, the impedance will near an open circuit andbe characteristic of the bag layer material conductance with the spacingof the two electrodes. If the inner layer leaks, then fluids or othermaterial may enter the intermediate space. This fluid or foreignmaterial will provide a change in the impedance due to the conductivityof blood, tissue or other body fluids. By measuring a reduction in theimpedance between the two electrodes, a leak of fluids or other tissuethat spans the electrode spacing can be detected.

Some embodiments of leak detection include measuring complex impedance,such that a short circuit created with bag folds or other means may bedistinguished from the introduction of fluids or other bodily fluids ormaterial by using the power factor angle. This could also be enhancedwith adding a positive pressure to the intermediate space to reduce thechance of bag folds as well as designing the electrode shapes to alignwith areas of the bag that are expected to have folds so that a foldedbag may cause an electrode to contact itself and not contact theopposing electrode.

Since bodily fluids of a significant amount are likely to fall to thebottom of the bag, an electrode or series of electrodes at bottom of bagcan be used to detect when a fluid comes into contact with theelectrodes or circuit. The electrodes may sense a resistance orcapacitance. For example, the electrodes may have a liquid absorbing gelin the bottom of bag that changes capacitance if liquid is added.

Some embodiments of detecting a leak in the bag may include applying avolume of Helium (He) or inert gas into the contained intermediate spacebetween the inner and outer layers of the bag. Using a gas spectroscopydetection technique, a helium detector, or an inert gas detector, placedwithin the bag, incorporated into the instrument such that the sensor islocated within the introducer tube or located outside of the tube with alumen connected to the introducer tube such that the sensor can samplethe contents of the air flowing from inside the bag, such as in a smokeevacuation system. Any traces of helium or the inert gas indicatemigration of the gas from the intermediate space to the inside of thebag which in turn indicates a leak has occurred.

In some embodiments, the detector is placed through an additionallaparoscopic port such that any detection of helium or inert gas withinthe peritoneal cavity would indicate a lead between the intermediatespace of the bag and the outer bag layer. This method may includesuspending the insufflation while measuring for a leak.

Some methods of leak detection may include optically scanning for a leakduring or after the surgical procedure.

Some embodiments of leak detection methods include using a camera toview the surface of the bag during the procedure. The camera may beinserted through a separate port and may be the endoscopic camera usedduring laparoscopy, or could be a separate camera intended to detectleaks. The image of the camera may be sent to a processing unit, such asthe controller previously described herein or a different unit that candigitize the image in real time. The processing unit may also contain adatastore to store digitized images that can be used to compare realtime imaging data. This comparison can be used to determine changes inthe geometry of the bag as the procedure proceeds, such as theintermediate space thickness, which can provide an indication of a bagleak. The visual image can also look for a buildup of fluids on thesurface or bottom of the bag, can look for drops forming or falling fromthe bag and can be used in conjunction with some of the otherembodiments presented in this disclosure. For example, if a material isplaced within the intermediate space that has a particular color, afiltering algorithm can be used by the processor to identify changes inamplitude of this color on the outer surface of the bag.

Some embodiments include comparing a bag after the procedure is completeto a measurement taken before placement of the bag into the patient orto manufacturers' specifications.

With reference now to FIGS. 97a-97c , some embodiments of leak detectioninclude providing or using an audible or visual indicator 9708 thatexpands or “pops” when a vacuum pressure in a space 9706 between two baglayers 9702, 9704 is lost (compare to a canning jar lid that pops whenopened). For example, if a breach in either the inner or outer bag 9702,9704 occurs, the vacuum loss indicator 9708 feature will pop, extend, orchange from a first state of tension to a second state, to indicate tothe surgeon that a breach in either layer of the bag has caused the voidspace between the two layers of specimen bag to lose its vacuum.

Some embodiments of leak detection may include providing or using acolor changing moisture indicator between bag layers. For example, thespecimen bag layers may be constructed of two welded layers ofpolyurethane, creating a sealed inner space between the two layers. Acompromise or leak in either of these two layers may be indicated by acolor changing chemical agent that would be applied to the inner spaceduring bag construction. When the chemical indicator comes in contactwith water based, human fluids a chemical reaction with the fluid wouldcreate a color change in the agent that would be observable either fromthe endoscopic camera in the body cavity or observable directly by thesurgeon after bag removal. The agent may be sprayed on to either or bothinner walls of the polyurethane during assembly of the bag. The agentmay also be inserted in construction as a loose powder or as a film ofliquid. Strips of colored paper or fiber may hold the color changingagent.

In some embodiments, a liquid agent may be inserted through a port afterthe bag is placed in the body. A color change between the two layerswould only indicate that, at least, one of the two layers had beencompromised since fluids could have passed from either side into theinner space. A follow up test may be useful to verify which of thelayers had been perforated.

In some embodiments useful for leak detection, a spray-on coating on aninternal surface of the outer bag may be provided and configured to bindto liquid. After the procedure, a visual inspection of the outer surfaceof the inner bag and/or the inner surface of the outer bag, using, forexample, black light, may reveal if a leak has occurred.

To identify liquid escape from a breached inner bag layer, a coating onthe outer-side of the inner specimen bag layer. This coating, whencombined with bodily fluid, may be configured to bind with theinfiltrating fluid, thereby creating a marker which may be visualizedwith the naked eye, and/or with the aid of secondary equipment, such asa black light. Inspection for a breach in the inner bag layer may beincorporated as a procedure after every specimen removal procedure byscanning each post-operative bag to look for the presence of this breachmarker.

Some embodiments of leak detection methods and devices may include usinga water color “no mess” markers pad that changes color in the presenceof liquid. That is, to visually indicate a breach in the inner baglayer, a coating, similar to a dry watercolor pigment, may be applied tothe void between the inner and outer bag during specimen bagmanufacturing. If this void is breached & body fluids infiltrate thisvoid space then the dry pigment will become saturated and provide avisual identification of a breached inner bag layer.

Some embodiments of leak detection methods and devices may include afinger print “dust” for leak detection. Similar to the watercolorpigment method and device described above, a powder may be inserted inthe void space between the two layers of the specimen bag. Infiltrationof body fluids into this space would turn the powder to a paste-linksubstance. This paste substance would make a visual identification of abreached inner bag layer possible.

In some embodiments, a color changing material may be used as one of thebag layers or in addition to and between the bag layers. If either ofthe bag layers is breached, the color changing material would changecolors as a visual indication of the breach. For example, the materialin between layers changes color when CO2 or N2O, which are typicalinsufflation gases, enter the space between the bag layers.

Some embodiments include using a color changing material at the bottomof bag only that absorbs any fluids that are within the layers. Thiscolor changing material may be configured to change color as a result ofa protein, fluid, or other chemical signature of a biologic fluid.

Some embodiments of leak detection methods or devices include the use ofa visual indicator, which may be with or without a camera betweenlayers. To provide a visual indication of whether or not a breachoccurred in the inner bag, the outer bag layer may be made of a white orsimilarly contrasting material such that the surgeon can look for bloodon inside of outer white layer either during the instrument, use such aswith a camera, or after use. Discoloration of the outer bag innersurface may indicate that a breach of the inner bag layer has occurred.

Some embodiments of leak detection devices 9700 and methods may includethe use of one or more vacuum loss indicators, such as indicator tubesor geometries, as illustrated in FIG. 97. For example, one or morepockets, tubes or expansion members 9708 may be positioned at locationsaround the outer layer 9702 of the bag assembly. One or more expansionmembers 9708 may be non-distinct in a normal relaxed state, and, undernormal conditions, with a fully contained and pressurized bag assembly,the geometries would remain in the relaxed state. If a leak occurs,however, in the inner bag layer 9702, the expansion member 9708 on theouter layer 9702 would expand, providing an easily identifiableindication of an inner bag layer leak.

Embodiments of leak management are also described herein, to mitigateany adverse effects that may be caused by a leak. For example, in someembodiments, a chemotherapy agent specific to the procedure beingperformed may be placed in the interior space of the bag 161. The agentmay be pre-placed into the bag, such as during manufacturing orpre-packaging of the bag, or the agent may be positioned in the bagin-situ.

In some embodiments, a chemotherapy agent in the space between the baglayers may be configured to kill cells on contact. The agent may be aspecific agent that is chosen or configured to target the intendedprocedure.

In some embodiments, the agent is contained in a hydrogel or gel suchthat any cells that come into contact with the agent are likely to stickor adhere to the surface of the hydrogel or gel.

The chemotherapy agent may be selected based on the procedure and/orpatient history. For example, if a uterus is being removed, achemotherapy agent that would be indicated for a leiomysarcoma suitablefor the patient may be used to best address any cancer cells that maymigrate into the interior space of the bag or the space between baglayers.

For colon removal an agent that is indicated for an adenocarcinoma maybe selected and placed in the bag.

In some embodiments, the surgeon and/or oncologist selects thechemotherapy agent and adds the agent to the space between the outer andinner layers just prior to use.

In some embodiments, the surgeon and/or oncologist may select from arange of pre-administered chemotherapy agents that are placed in the bagor between bag layers during manufacturing. The agent maybe applied inthe form of a liquid with a safe quantity applied or may be applied as afilm to either the outside layer of the inner bag or the inside layer ofthe outer bag.

In some embodiments of leak mitigation, an antiseptic or disinfectantsolution of layer may be provided in a manner substantially similar tothat described with respect to the chemotherapy agent previouslydescribed herein.

Some embodiments of leak mitigation include placing or using a layer ofabsorbent material in between the inner and outer bag layers such thatif a leak occurs in the inner layer, the absorbent material will containan amount of fluids or other material that breach the inner layer. Thisalso provides some protection to resist both layers of the bag beingdamaged by instruments or other mechanical edges. The absorbent materialmay be a fabric, a foam, gel or other material that has highly absorbentproperties to water.

Some embodiments of leak mitigation include providing or using anabsorbent material that changes hardness or phases when in contact witha fluid. The material may be placed between the bag layers. It may be adry substance that turns to a gel in some embodiments. In someembodiments, the substance may turn harder or softer, may be a powder orfilm that turns to a gel, or may change colors as a result of achemically activated change. The material may change phases so as to bedetected either visually, through physical palpation of the bag, etc.

Some embodiments of leak mitigation may include the use of or placementof a layer of viscous gel material between the inner and outer baglayers such that, if a leak occurs, the gel is configured to minimizethe impact of a leak. The gel may, in some embodiments, close the leak;in some embodiments, the leak may increase the thickness of the bag suchthat a leak would have a lower probability of penetrating both the innerand outer bag layers and the gel layer. In some embodiments, the gel maybe made of or include a biocompatible material. In some embodiments, thegel may include a hydrogel, such as that placed on return electrodes. Insome embodiments, the gel includes a hydrophilic polymeric material, abiodegradable hydrophilic material, and/or an organic hydrophilicmaterial. The gel may be added to the space between layers atmanufacturing; or the gel may be added through a lumen in-situ.

The gel may be selected and configured to thermally insulate the outerlayer from the inner layer, thereby reducing the likelihood of a breachof both layers.

Some embodiments of leak mitigation include the use of a multi-cellintermediate layer. A multi-cell layer between the outer bag layer andthe inner bag layer may include a number of interior spaces that serveto reduce the volume of fluid that may potentially leak in the event theinner layer is compromised. For example, a number of walls coupling theinner layer and the outer layer may form a number of smaller fixedvolumes of air, fluid, gel, or other leak mitigation or leak managementmeans described herein within the space between the inner and outerlayers of the bag.

In some embodiments, the smaller fixed volumes of air fluid, gel, orother leak mitigation or leak management means described herein may beprovided by a third bag layer positioned between the inner layer and theouter layer. The third layer may include an inner wall, an outer wall,and a number of connecting walls coupling the inner wall and the outerwall, creating the fixed volumes therebetween.

In some embodiments, a multi-cell layer may include a plurality ofsealed pockets of a fluid or a leak mitigation means. The multi-celllayer may be positioned between the inner layer and the outer layer. Themulti-cell layer may limit travel of contaminated material and reducethe probability of contaminated material such as portions of a canceroussegmented tissue sample breaching the bag assembly. The multi-cell layermay be positioned exterior of both bag layers in some embodiments.

Some embodiments of leak mitigation may include the use of a materialthat solidifies when it comes in contact with bodily fluid. For example,an epoxy or any thermosetting material may be provided in the spacebetween the outer and inner bag layers. The thermosetting material maybe configured to solidify or harden in the event a breach of the innerbag layer allows material to reach the intermediate space. In someembodiments, the solidification may plug the breach. In someembodiments, the thermosetting material may be selected or configured toset within a period of time. The period of time may be five minutes orless in some embodiments. The period of time may be two minutes or lessin some embodiments. The period of time may be one minute or less insome embodiments. The period of time may be thirty seconds or less insome embodiments. The period of time may be fifteen seconds or less insome embodiments.

Those skilled in the art will recognize that a faster setting of thethermosetting material may result in a weaker bond; however, thisfeature may be advantageous by enabling the surgeon to, after completingthe segmentation procedure, break up the set materials and remove themthrough the incision site. Breaking up the set materials may be achievedwithout destroying the outer bag layer in some embodiments.

In some embodiments, a material that is reactive with carbon dioxideand/or nitrous oxide may be used or placed in the space between theouter and inner layers. The reactive material may be selected orconfigured to form a foam or gel, or to solidify, thereby mitigating theeffects of any breach of the inner bag layer.

Embodiments

1. A tissue removal bag assembly, comprising: an inner bag layer havingan interior surface and an exterior surface; an outer bag layer havingan interior surface and an exterior surface, the outer bag layer coupledto the inner bag layer and forming a space between the exterior surfaceof the inner bag layer and the interior surface of the outer bag layer.

2. The assembly of embodiment 1, further comprising: a sensor exposed tothe space, the sensor configured to detect pressure in the space.

3. The assembly of embodiment 1 or 2, further comprising: an inflationmechanism coupled to and configured to inflate the space between theinner bag layer and outer bag layer.

4. The assembly of embodiment 1-3, further comprising: a color changingindicator responsive to and configured to indicate a breach in the innerbag layer.

5. The assembly of embodiment 1-4, further comprising: a conductivedeposition between the outer bag layer and the inner bag layer, theconductive deposition configured to indicate a breach in the inner baglayer.

6. The assembly of embodiment 1-5, further comprising: a fluid in thespace.

7. The assembly of embodiment 1-6, further comprising: a sensor exposedto the space, the sensor configured to detect at least one of carbondioxide or nitrous oxide.

8. The assembly of embodiment 1-7, further comprising: a vacuum lossindicator configured to indicate a loss of negative pressure between theouter bag layer and the inner bag layer.

9. The assembly of embodiment 8, wherein: the vacuum loss indicatorcomprises an expansion member, the expansion member configured to movefrom a compressed configuration to an expanded configuration in responseto a loss of negative pressure between the outer bag layer and the innerbag layer.

10. The assembly of embodiment 1-9, further comprising: at least one ofa hydrogel, a chemotherapy agent, or an absorbent material positionedbetween the outer bag layer and the inner bag layer.

11. The assembly of embodiment 1-10, further comprising: a plurality ofsealed pockets positioned between the outer bag layer and the inner baglayer.

12. The assembly of embodiment 11, further comprising: a plurality ofwalls coupling the outer bag layer to the inner bag layer to form theplurality of sealed pockets.

13. The assembly of embodiment 11, further comprising: a third baglayer, the third bag layer having an inner wall, an outer wall, and anumber of connecting walls coupling the inner wall and the outer walland forming the plurality of sealed pockets.

14. The assembly of embodiment 11-13, wherein: at least one of theplurality of sealed pockets contains at least one of air, a fluid, agel, a hydrogel, a thermosetting material, an absorbent material, achemotherapy agent, or a color changing material.

15. The assembly of embodiment 1-10, further comprising: a third baglayer, the third bag layer having an inner wall, an outer wall, and anumber of connecting walls coupling the inner wall and the outer walland forming the plurality of sealed pockets.

16. The assembly of embodiment 15, wherein: the third bag layer isinterior of the outer bag layer.

17. The assembly of embodiment 1-16, further comprising: a thermosettingmaterial positioned interior of the outer bag layer and configured tosolidify when exposed to bodily fluid.

18. The assembly of embodiment 17, wherein: the thermosetting materialis configured to solidify within a period of time of exposure to thebodily fluid.

19. The assembly of embodiment 18, wherein: the period of time is oneminute or less.

20. The assembly of embodiment 1-19, further comprising: a colorchanging indicator positioned interior of the outer bag layer, the colorchanging material having a material selected to change from a firstcolor to a second color in response to exposure to at least one ofnitrous oxide, carbon dioxide, or bodily fluid.

21. The assembly of embodiment 1-20, wherein: the outer bag layer has afirst color; the inner bag layer has a second color; and wherein contactbetween the outer bag layer and the inner bag layer results in a thirdcolor observed.

22. A tissue segmentation device having at least one active electrode, areturn electrode, a mechanical force application mechanism, a voltagesensor, a current sensor, and a controller. The controller is configuredto control a power output of the segmentation device. The controller hasa processing component, responsive to the voltage sensor and the currentsensor, configured to execute the following: (a) derive a power factorof power applied to the at least one electrode; and (b) responsive tothe deriving a power factor, assign a circuit status to a circuitcomprising the at least one electrode, according to the following: IF(PF≈0) and ((Vrms/Irms)≧T), THEN the circuit status is “open”. IF (PF≈0)and ((Vrms/Irms)<T), THEN the circuit status is “short”. PF is the powerfactor. Vrms is the root mean square of a voltage associated with thepower applied to the at least one electrode. Irms is the root meansquare of a current associated with the power applied to the at leastone electrode. T is a threshold value.

23. A controller for a tissue segmentation device having at least oneactive electrode, a return electrode, a voltage sensor, a currentsensor, and a mechanical force application mechanism. The controller hasa processing component, responsive to the voltage sensor and the currentsensor, configured to execute the following: (a) derive a power factorof power applied to the at least one electrode; and (b) responsive tothe deriving a power factor, assign a circuit status to a circuitcomprising the at least one electrode according to the following: IF(PF≈0) and ((Vrms/Irms)≧T), THEN the circuit status is “open”. IF (PF≈0)and ((Vrms/Irms)<T), THEN the circuit status is “short”. PF is the powerfactor. Vrms is the root mean square of a voltage associated with thepower applied to the at least one electrode. Irms is the root meansquare of a current associated with the power applied to the at leastone electrode. T is a threshold value.

24. A method of tissue segmentation. The method includes providing atissue segmentation device having at least one active electrode, areturn electrode, a mechanical force application mechanism, a voltagesensor, and a current sensor. The method includes deriving a powerfactor of power applied to the at least one electrode, and responsive toderiving a power factor, assigning a circuit status to a circuitcomprising the at least one electrode according to the following: IF(PF≈0) and ((Vrms/Irms)≧T), THEN the circuit status is “open”; IF (PF≈0)and ((Vrms/Irms)<T), THEN the circuit status is “short”. PF is the powerfactor. Vrms is the root mean square of a voltage associated with thepower applied to the at least one electrode. Irms is the root meansquare of a current associated with the power applied to the at leastone electrode. T is a threshold value.

25. A tissue segmentation device. The device has at least one activeelectrode, a return electrode, a mechanical force application mechanism,a voltage sensor, a current sensor, and a controller. The controller isconfigured to control a power output of the segmentation device. Thecontroller has a processing component, responsive to the voltage sensorand the current sensor, configured to execute the following: (a) derivean impedance to power applied to the at least one electrode; and (b)responsive to the deriving the impedance, assign a circuit status to acircuit comprising the at least one electrode, according to thefollowing: IF (Z>T1), THEN the circuit status is “open”; and IF (Z<T2),THEN the circuit status is “short”; where Z is the impedance; T1 is afirst threshold value; and T2 is a second threshold different from thefirst threshold value.

Each of the various elements disclosed herein may be achieved in avariety of manners. This disclosure should be understood to encompasseach such variation, be it a variation of an embodiment of any apparatusembodiment, a method or process embodiment, or even merely a variationof any element of these. Particularly, it should be understood that thewords for each element may be expressed by equivalent apparatus terms ormethod terms—even if only the function or result is the same. Suchequivalent, broader, or even more generic terms should be considered tobe encompassed in the description of each element or action. Such termscan be substituted where desired to make explicit the implicitly broadcoverage to which this invention is entitled.

As but one example, it should be understood that all action may beexpressed as a means for taking that action or as an element whichcauses that action. Similarly, each physical element disclosed should beunderstood to encompass a disclosure of the action which that physicalelement facilitates. Regarding this last aspect, the disclosure of a“cutting mechanism” should be understood to encompass disclosure of theact of “cutting”—whether explicitly discussed or not—and, conversely,were there only disclosure of the act of “cutting”, such a disclosureshould be understood to encompass disclosure of a “cutting mechanism”.Such changes and alternative terms are to be understood to be explicitlyincluded in the description.

The previous description of the disclosed embodiments is provided toenable any person skilled in the art to make or use the presentinvention defined by the claims. Various modifications to theseembodiments will be readily apparent to those skilled in the art, andthe generic principles defined herein may be applied to otherembodiments without departing from the spirit or scope of the invention.Thus, the present invention is not intended to be limited to theembodiments shown herein but is to be accorded the widest scopeconsistent with the principles and novel features disclosed herein.

1-30. (canceled)
 31. A controller for an electrosurgical device, thecontroller configured to control a power output of the electrosurgicaldevice, the controller comprising a processing component configured toexecute the following: (a) derive a power factor of power applied to theelectrosurgical device and (b) responsive to the deriving a powerfactor, assign a circuit status to a circuit comprising theelectrosurgical device; wherein IF (PF≈0) and ((Vrms/Irms)≧T), THEN thecircuit status is “open”; and IF (PF≈0) and ((Vrms/Irms)<T), THEN thecircuit status is “short”; where PF is the power factor; Vrms is theroot mean square of a voltage associated with the power applied to theat electrosurgical device; Irms is the root mean square of a currentassociated with the power applied to the electrosurgical device; and Tis a threshold value.
 32. The controller of claim 31, wherein:PF=Preal/(Vrms*Irms); where Preal is a real power being delivered to theelectrosurgical device.
 33. The controller of claim 31, wherein theelectrosurgical device is a tissue segmentation device having at leastone active electrode; and the processing component is further configuredto execute the following: compare a first rate of travel of the at leastone active electrode to at least one of a rate of travel parameter, asecond rate of travel of the at least one active electrode, or a firstrate of travel of a second active electrode; and responsive to thecomparing a first rate of travel, adjust a tissue segmentation controlsignal to effectuate a change in at least one of a voltage applied tothe at least one active electrode, a current applied to the at least oneactive electrode, or a power applied to the at least one activeelectrode.
 34. The controller of claim 31, wherein the electrosurgicaldevice is a tissue segmentation device having at least one activeelectrode; and the processing component is further configured to executethe following: compare a distance of travel of the at least one activeelectrode to an expected distance of travel parameter of the at leastone active electrode; and assign a segmentation status to the circuitcomprising the at least one active electrode; wherein if the circuitstatus is “open” and the distance of travel is equal to or greater thanthe expected distance of travel, then the segmentation status is“complete”.
 35. The controller of claim 31, wherein the electrosurgicaldevice is a tissue segmentation device having at least one activeelectrode; and the processing component is further configured to executethe following: compare a distance of travel of the at least one activeelectrode to an expected distance of travel parameter of the at leastone active electrode; and assign a segmentation status to the circuitcomprising the at least one active electrode; wherein if the circuitstatus is “open” and the distance of travel is less than the expecteddistance of travel, then the segmentation status is “incomplete”. 36.The controller of claim 31, wherein the processing component is furtherconfigured to execute the following: responsive to assigning a circuitstatus of “short”, adjust a control signal to effectuate a change inpower applied to the electrosurgical device.
 37. The controller of claim31, wherein at least one of: responsive to an input from a temperaturesensor, the processing component is configured to adjust a controlsignal to effectuate a change in at least one of a voltage applied tothe electrosurgical device, a current applied to the electrosurgicaldevice, or a power applied to the electrosurgical device; or responsiveto an input from a force sensor, the processing component is configuredto adjust the control signal to effectuate a change in at least one ofthe voltage applied to the electrosurgical device, the current appliedto the electrosurgical device, or the power applied to theelectrosurgical device.
 38. A method, comprising: providing anelectrosurgical device and a controller, the controller having aprocessing component; deriving a power factor of power applied to anelectrosurgical device; and responsive to the deriving a power factor,assigning a circuit status to a circuit comprising the electrosurgicaldevice; wherein IF (PF≈0) and ((Vrms/Irms)≧T), THEN the circuit statusis “open”; and IF (PF≈0) and ((Vrms/Irms)<T), THEN the circuit status is“short”; where PF is the power factor; Vrms is the root mean square of avoltage associated with the power applied to the electrosurgical deice;Irms is the root mean square of a current associated with the powerapplied to the electrosurgical device; and T is a threshold value. 39.The method of claim 38, wherein: PF=Preal/(Vrms*Irms); where Preal is areal power being delivered to the electrosurgical device.
 40. Anelectrosurgical device, comprising: a voltage sensor; a current sensor;at least one electrode; and a controller configured to control a poweroutput of the at least one electrode, the controller comprising aprocessing component, responsive to the voltage sensor and the currentsensor, configured to execute the following: (a) derive a power factorof power applied to the electrosurgical device; and (b) responsive tothe deriving a power factor, assigning a circuit status to a circuitcomprising the electrosurgical device; wherein IF (PF≈0) and((Vrms/Irms)≧T), THEN the circuit status is “open”; and IF (PF≈0) and((Vrms/Irms)<T), THEN the circuit status is “short”; where PF is thepower factor; Vrms is the root mean square of a voltage associated withthe power applied to the electrosurgical deice; Irms is the root meansquare of a current associated with the power applied to theelectrosurgical device; and T is a threshold value.
 41. The device ofclaim 40, wherein: PF=Preal/(Vrms * Irms); where Preal is a real powerbeing delivered to the electrosurgical device.